Friday, December 31, 2010

Research links rise in Falluja birth defects and cancers to US assault/ The Guardian

• Defects in newborns 11 times higher than normal
• 'War contaminants' from 2004 attack could be cause 

By Martin Chulov at the Guardian
US marines prepare for Fallujah offensive
White phosphorous smoke screens are fired by the US army as part of an early morning patrol in November 2004 on the outskirts of Falluja, Iraq, in preparation for an offensive against insurgents. Photograph: Scott Nelson/Getty Images

A study examining the causes of a dramatic spike in birth defects in the Iraqi city of Falluja has for the first time concluded that genetic damage could have been caused by weaponry used in US assaults that took place six years ago.
The research, which will be published next week, confirms earlier estimates revealed by the Guardian of a major, unexplained rise in cancers and chronic neural-tube, cardiac and skeletal defects in newborns. The authors found that malformations are close to 11 times higher than normal rates, and rose to unprecedented levels in the first half of this year – a period that had not been surveyed in earlier reports.
The findings, which will be published in the International Journal of Environmental Research and Public Health, come prior to a much-anticipated World Health Organisation study of Falluja's genetic health. They follow two alarming earlier studies, one of which found a distortion in the sex ratio of newborns since the invasion of Iraq in 2003 – a 15% drop in births of boys...

The report identifies metals as potential contaminating agents afflicting the city – especially among pregnant mothers. "Metals are involved in regulating genome stability," it says. "As environmental effectors, metals are potentially good candidates to cause birth defects...

The report acknowledges that other battlefield residues may also be responsible for the defects. "Many known war contaminants have the potential to interfere with normal embryonic and foetal development," the report says. "The devastating effect of dioxins on the reproductive health of the Vietnamese people is well-known..."

Birth-defect rates in Falluja have become increasingly alarming over the past two years. In the first half of 2010, the number of monthly cases of serious abnormalities rose to unprecedented levels. In Falluja general hospital, 15% of the 547 babies born in May had a chronic deformity, such as a neural tune defect – which affects the brain and lower limbs – cardiac, or skeletal abnormalities, or cancers.
No other city in Iraq has anywhere near the same levels of reported abnormalities. Falluja sees at least 11 times as many major defects in newborns than world averages, the research has shown...

Tuesday, December 28, 2010

Iraq Wants the U.S. Out/ WSJ

From an exclusive interview with the WSJ:
BAGHDAD—Prime Minister Nouri al-Maliki ruled out the presence of any U.S. troops in Iraq after the end of 2011, saying his new government and the country's security forces were capable of confronting any remaining threats to Iraq's security, sovereignty and unity.
Prime Minister Nouri al-Maliki sat down for an exclusive conversation with The Wall Street Journal's Sam Dagher. Here are some excerpts.

Mr. Maliki spoke with The Wall Street Journal in a two-hour interview, his first since Iraq ended nine months of stalemate and seated a new government after an inconclusive election, allowing Mr. Maliki to begin a second term as premier.
A majority of Iraqis—and some Iraqi and U.S. officials—have assumed the U.S. troop presence would eventually be extended, especially after the long government limbo. But Mr. Maliki was eager to draw a line in his most definitive remarks on the subject. "The last American soldier will leave Iraq" as agreed, he said, speaking at his office in a leafy section of Baghdad's protected Green Zone. "This agreement is not subject to extension, not subject to alteration. It is sealed."

Sunday, December 26, 2010

Kleptocracy Nation: Retired Generals and Admirals working for defense contractors/ Boston Globe

From Bryan Bender at the Globe:
Former officers and specialists say the defense industry’s political might is getting a new boost from an accelerating flow of retired generals and admirals.
The Department of Defense... runs an exclusive job service to teach soon-to-retire generals how to land jobs in the defense industry. And military firms routinely recruit elite officers while they are still in uniform.
In rare cases, generals have gone so far as to establish their own consulting firms before retirement...
The defense industry pays large sums to the retired flag officers it hires. For the rapidly growing corps of consultants, fees reach thousands of dollars a day; monthly retainers can run between $20,000 and $50,000 for individual clients. The busiest and most influential retired generals are earning millions of dollars a year, according to industry sources...
Intense competition for contracts is helping drive the industry’s insatiable desire for influential and well-connected insiders.
So is the burgeoning business of outsourcing war...

Saturday, December 25, 2010

Kleptocracy Nation: Lawmakers seek cash during key votes/ WaPo

From Carol D. Leonnig and T.W. Farnam at the Washington Post:
Numerous times this year, members of Congress have held fundraisers and collected big checks while they are taking critical steps to write new laws, despite warnings that such actions could create ethics problems. The campaign donations often came from contributors with major stakes riding on the lawmakers' actions.
For three weeks in June, for instance, the members of a joint House and Senate committee worked to draft final rules for regulating the financial industry in the wake of its 2008 meltdown. During that time, the 35 members of the drafting committee collected $440,000 in donations from that same industry, which was then lobbying heavily for looser rules.
... ethics watchdogs complain that, in a race for money to help them win reelection, lawmakers routinely ignore congressional ethics rules that urge them to avoid fundraising around the same time that they are making key lawmaking decisions...
In September, the Senate voted on what it considered one of the year's most important pieces of legislation, the Small Business Job Creation Act. The bill, which later became law, created a $30 billion loan fund for community banks and gave them incentives to lend the money to small businesses. Hundreds of lobbyists were registered to lobby on this legislation, in part because it meant more business for banks.

Senators collected $469,000 from the financial industry the day before, the day of and the day after that key Sept. 16 vote, a Post review of donations shows. The biggest recipient was Senate Majority Leader Harry M. Reid (D-Nev.), who shepherded the legislation and faced a tight reelection race...

Friday, December 24, 2010

Making the unacceptable "legal" (in this case, indefinite detention without trial) via Executive Order (but it's still unconstitutional)/ HuffPo

Bill Quigley (Loyola University Law Professor) and Vince Warren (both associated with the Center for Constitutional Rights) discuss Obama's newest Executive Order:  one designed to uproot the 5th Amendment's requirement for due process and the 6th Amendment's rights of the accused, including the right to a speedy trial.  Here is their report on Huffington Post:
The right to liberty is one of the foundation rights of a free people. The idea that any US President can bypass Congress and bypass the courts by issuing an executive order setting up a new legal system for indefinite detention of people should rightfully scare the hell out of the American people.
Advisors in the Obama administration have floated the idea of creating a special new legal system to indefinitely detain people by executive order. Why? To do something with the people wrongfully imprisoned in Guantanamo. Why not follow the law and try them? The government knows it will not be able to win prosecutions against them because they were tortured by the US.
Guantanamo is coming up on its ninth anniversary -- a horrifying stain on the character of the US commitment to justice. President Obama knows well that Guantanamo is the most powerful recruitment tool for those challenging the US. Unfortunately, this proposal for indefinite detention will prolong the corrosive effects of the illegal and immoral detentions at Guantanamo rightly condemned world-wide.
The practical, logical, constitutional and human rights problems with the proposal are uncountable.
Our system provides a simple answer developed over hundreds of years -- try them or release them. Any other stop gap measure like the one proposed merely pushes the problem back down the road and back into the courts again. While it may appear to be a popular political response, the public will soon enough see this for what it is -- an unconstitutional usurping of power by the executive branch and a clear and present danger to all Americans...
Recall that dozens of the very same people who would now be subject to indefinite detention have already been cleared for release by the government. How can indefinite detention of people we already cleared to go home possibly be legal?

... "Freedom from bodily restraint has always been at the core of the liberty protected by the Due Process Clause from arbitrary governmental action." The Supreme Court has "always been careful not to "minimize the importance and fundamental nature of the individual's right to liberty." Foucha v Louisiana, 504 US 71 (1992).

The liberty of all persons is protected by the criminal process guarantees, among other rights: the right to be free from unreasonable searches and seizures; probable cause for arrest; right to counsel, right to indictment by grand jury; right to trial by an impartial jury; the right to a speedy public trial; the presumption of innocence; the right that government must prove beyond a reasonable doubt every fact necessary to make out the charged offense; a privilege against self-incrimination; the right to confront and cross examine witnesses; the right to present witnesses and use compulsory process; the duty on the government to disclose exculpatory evidence...
Or at least it seemed to be like that in the USA, once upon a time...

Monday, December 20, 2010

Monitoring America/ Washington Post

The Washington Post team of Dana Priest and William Arkin have again pushed the envelope on what the mainstream media report on US government surveillance of citizens.  I expect that, as happened congruent to Priest and Arkin's stories on "Top Secret America" published last July, the Post will build a site with a linked set of materials online over the next several days.  Scroll down to the bottom of page 1 to see some of this material.
Nine years after the terrorist attacks of 2001, the United States is assembling a vast domestic intelligence apparatus to collect information about Americans, using the FBI, local police, state homeland security offices and military criminal investigators.
The system, by far the largest and most technologically sophisticated in the nation's history, collects, stores and analyzes information about thousands of U.S. citizens and residents, many of whom have not been accused of any wrongdoing.
The government's goal is to have every state and local law enforcement agency in the country feed information to Washington to buttress the work of the FBI, which is in charge of terrorism investigations in the United States...

The total cost of the localized system is also hard to gauge. The DHS has given $31 billion in grants since 2003 to state and local governments for homeland security and to improve their ability to find and protect against terrorists, including $3.8 billion in 2010. At least four other federal departments also contribute to local efforts. But the bulk of the spending every year comes from state and local budgets that are too disparately recorded to aggregate into an overall total.

The Post findings paint a picture of a country at a crossroads, where long-standing privacy principles are under challenge by these new efforts to keep the nation safe.
The public face of this pivotal effort is Napolitano, the former governor of Arizona, which years ago built one of the strongest state intelligence organizations outside of New York to try to stop illegal immigration and drug importation...

* In Arizona, the Maricopa County Sheriff's Facial Recognition Unit, using a type of equipment prevalent in war zones, records 9,000 biometric digital mug shots a month.
* U.S. Customs and Border Protection flies General Atomics' Predator drones along the Mexican and Canadian borders - the same kind of aircraft, equipped with real-time, full-motion video cameras, that has been used in wars in Kosovo, Iraq and Afghanistan to track the enemy.
The special operations units deployed overseas to kill the al-Qaeda leadership drove technological advances that are now expanding in use across the United States. On the front lines, those advances allowed the rapid fusing of biometric identification, captured computer records and cellphone numbers so troops could launch the next surprise raid.
Here at home, it's the DHS that is enamored with collecting photos, video images and other personal information about U.S. residents in the hopes of teasing out terrorists...

At the same time that the FBI is expanding its West Virginia database, it is building a vast repository controlled by people who work in a top-secret vault on the fourth floor of the J. Edgar Hoover FBI Building in Washington. This one stores the profiles of tens of thousands of Americans and legal residents who are not accused of any crime. What they have done is appear to be acting suspiciously to a town sheriff, a traffic cop or even a neighbor...
Private enterprise saw what the government was up to and decided they too could get away with collecting data on citizens--for profit.  And their data collection may extend to identifying their friends.  Check out the WSJ article, "Your Apps Are Watching You" for info like the following:

Few devices know more personal details about people than the smartphones in their pockets: phone numbers, current location, often the owner's real name—even a unique ID number that can never be changed or turned off.
These phones don't keep secrets. They are sharing this personal data widely and regularly, a Wall Street Journal investigation has found.
An examination of 101 popular smartphone "apps"—games and other software applications for iPhone and Android phones—showed that 56 transmitted the phone's unique device ID to other companies without users' awareness or consent. Forty-seven apps transmitted the phone's location in some way. Five sent age, gender and other personal details to outsiders...
Smartphone users are all but powerless to limit the tracking. With few exceptions, app users can't "opt out" of phone tracking, as is possible, in limited form, on regular computers. On computers it is also possible to block or delete "cookies," which are tiny tracking files. These techniques generally don't work on cellphone apps...
Apple has signaled that it has ideas for targeting people more closely...  How would Apple learn who a cellphone user's friends are, and what kinds of media they prefer? The patent says Apple could tap "known connections on one or more social-networking websites" or "publicly available information or private databases describing purchasing decisions, brand preferences," and other data...

Saturday, December 18, 2010

News? No. Vaccines with adjuvants induce stronger immune responses, but SAFETY is the issue/ Reuters

Reuters makes big news of a study showing that Glaxo's swine flu vaccine (which contains ASO3 adjuvant) induced a stronger immune response than an unadjuvanted Baxter vaccine.

This is nothing to crow about.  Everyone agrees that adjuvants boost the immune response; the question is how much increased autoimmune illness or other adverse events occur as a result of the adjuvant boost.  Norman Baylor, director of FDA's Office of Vaccine Research and Review, told Science magazine that antigen-sparing strategies [using a cheaper adjuvant to reduce the amount of antigen in vaccine--Nass] benefit populations, not individuals. "You have to think about those trade-offs," Baylor said.

Another issue is whether the "stronger immune response" actually prevents flu in more people.  Data from many studies of flu vaccines show that the vaccines are up to 75% effective at preventing flu, when the vaccine strains match the common circulating flu strain(s).  So far, there is no evidence that adjuvanted vaccines do better than 75%.

Furthermore, flu vaccines do not lead to reduced hospitalizations or complications from influenza (which is what causes flu-related deaths) and there is no evidence adjuvanted vaccines do either.  So the higher levels of antibodies achieved with adjuvanted vaccines may not produce any clinical beneft whatsoever.

Remember, every medical intervention is associated with cost and with risks and benefits. The extent of the benefit must exceed the risk.  That has not been shown for ASO3 or other novel adjuvants.  Reuters can cheerlead all it wants to, but these adjuvants are not ready for prime time.  Until we have a much better idea of the adverse event profile of last year's adjuvanted swine flu vaccines (used in most countries in 2009 but not in the US due to safety concerns) it is premature to use these products in mass vaccination programs.  [A joint FDA-NIH conference on how to study the safety of adjuvants was held in December 2008 and can be accessed here.]

Where are the data from the US and the rest of Europe and Australia on narcolepsy incidence following swine flu vaccinations?  Why have Sweden and Finland seen a steep rise in cases?  What other neurologic disorders, if any, have occurred at increased incidence?  These are only some of the questions that must be answered prior to adopting novel adjuvants for general use.

Tuesday, December 14, 2010

Narcolepsy diagnosed in 41 children vaccinated for H1N1 last year/ Helsingin Sanomat

Surge seen only in Sweden and Finland (Helsingen Sanomet)

Narcolepsy diagnosed in 41 children vaccinated for H1N1 last year
Forty one children and young people in Finland who were vaccinated for the H1N1, or swine flu virus last winter have been diagnosed with narcolepsy. In addition, there have been a few cases of the disease in which there was no record of a swine flu vaccination.
      Sweden and Finland are the only two countries to report a surge in narcolepsy the same vaccine was used in Canada, where there were only a few cases of the disease.

Narcolepsy has been on the increase in Finland in the past ten years, but not among such young patients. The symptoms of the young victims have been more severe than usual.
      “Kataplexy, the sudden loss of muscle tone in connection with a strong emotional state, has not been this common before”, says child neurologist Outi Saarenpää-Heikkilä of the Tampere University Hospital.
      “The symptoms are complicated and they are more severe than before. We have to learn how to treat it, because the medicines have not been intended for children, and they should not be used too easily. Older patients suffer most from personality changes - irritability and fits of rage. Going to school becomes impossible for some, and social life becomes more narrow.”
      Although the increase in cases of narcolepsy coincides with the vaccines, there is still some question as to whether or not it was actually the cause.
      The question was analysed on Monday when families affected by the disease and public health officials met at the Ministry of Social Affairs and Health. The families had little doubt about the connection...

WikiLeaks and 9/11: What if?/ LA Times

Coleen Rowley, retired special agent and legal counsel for the Minneapolis field office of the FBI, and Bogdan Dzakovic, former special agent for the FAA's security division, wrote this interesting piece:  
Frustrated investigators might have chosen to leak information that their superiors bottled up, perhaps averting the terrorism attacks.
If WikiLeaks had been around in 2001, could the events of 9/11 have been prevented? The idea is worth considering.The organization has drawn both high praise and searing criticism for its mission of publishing leaked documents without revealing their source, but we suspect the world hasn't yet fully seen its potential. Let us explain.
There were a lot of us in the run-up to Sept. 11 who had seen warning signs that something devastating might be in the planning stages. But we worked for ossified bureaucracies incapable of acting quickly and decisively. Lately, the two of us have been wondering how things might have been different if there had been a quick, confidential way to get information out.
One of us, Coleen Rowley, was a special agent/legal counsel at the FBI's Minneapolis division and worked closely with those who arrested would-be terrorist Zacarias Moussaoui on an immigration violation less than a month before the World Trade Center was destroyed.
Following up on a tip from flight school instructors who had become suspicious of the French Moroccan who claimed to want to fly a jet as an "ego boost," Special Agent Harry Samit and an INS colleague had detained Moussaoui. A foreign intelligence service promptly reported that he had connections with a foreign terrorist group, but FBI officials in Washington inexplicably turned down Samit's request for authority to search Moussaoui's laptop computer and personal effects.
Those same officials stonewalled Samit's supervisor, who pleaded with them in late August 2001 that he was "trying to keep someone from taking a plane and crashing into the World Trade Center." (Yes, he was that explicit.) Later, testifying at Moussaoui's trial, Samit testified that he believed the behavior of his FBI superiors in Washington constituted "criminal negligence."

The 9/11 Commission ultimately concluded that Moussaoui was most likely being primed as a Sept. 11 replacement pilot and that the hijackers probably would have postponed their strike if information about his arrest had been announced.WikiLeaks might have provided a pressure valve for those agents who were terribly worried about what might happen and frustrated by their superiors' seeming indifference. They were indeed stuck in a perplexing, no-win ethical dilemma as time ticked away. Their bosses issued continual warnings against "talking to the media" and frowned on whistle-blowing, yet the agents felt a strong need to protect the public.
The other one of us writing this piece, Federal Air Marshal Bogdan Dzakovic, once co-led the Federal Aviation Administration's Red Team to probe for vulnerabilities in airport security. He also has a story of how warnings were ignored in the run-up to Sept. 11. In repeated tests of security, his team found weaknesses nine out of 10 times that would make it possible for hijackers to smuggle weapons aboard and seize control of airplanes. But the team's reports were ignored and suppressed, and the team was shut down entirely after 9/11.
In testimony to the 9/11 Commission, Dzakovic summed up his experience this way: "The Red Team was extraordinarily successful in killing large numbers of innocent people in the simulated attacks …[and yet] we were ordered not to write up our reports and not to retest airports where we found particularly egregious vulnerabilities.... Finally, the FAA started providing advance notification of when we would be conducting our 'undercover' tests and what we would be checking."
The commission included none of Dzakovic's testimony in its report.
Looking back, Dzakovic believes that if WikiLeaks had existed at the time, he would have gone to it as a last resort to highlight what he knew were serious vulnerabilities that were being ignored.
The 9/11 Commission concluded, correctly in our opinion, that the failure to share information within and between government agencies — and with the media and the public — led to an overall failure to "connect the dots."
Many government careerists are risk-averse. They avoid making waves and, when calamity strikes, are more concerned with protecting themselves than with figuring out what went wrong and correcting it.
Decisions to speak out inside or outside one's chain of command — let alone to be seen as a whistle-blower or leaker of information — is fraught with ethical and legal questions and can never be undertaken lightly. But there are times when it must be considered. Official channels for whistle-blower protections have long proved illusory. In the past, some government employees have gone to the media, but that can't be done fully anonymously, and it also puts reporters at risk of being sent to jail for refusing to reveal their sources. For all of these reasons, WikiLeaks provides a crucial safety valve.
Coleen Rowley, a FBI special agent for more than 20 years, was legal counsel to the FBI field office in Minneapolis from 1990 to 2003. Bogdan Dzakovic was a special agent for the FAA's security division. He filed a formal whistle-blower disclosure against the FAA for ignoring the vulnerabilities documented by the Red Team. For the past nine years he has been relegated to entry-level staff work for the Transportation Security Administration.

Monday, December 13, 2010

David Kelly death: Daily Mail publishes legal document calling for a formal inquest

Today, the Daily Mail publishes for the first time the legal document which could trigger a full coroner's inquest into the death of Dr David Kelly.
The document, formally known as a memorial was written by group of campaigning doctors who have been trying to secure an inquest since 2004.
It lists the sequence of events which led up to Dr Kelly's death and the legal reasons they believe an inquest ought to be held...
The memorial argues that Dr Kelly’s death was not sufficiently investigated and claims that there are a large number of irregularities surrounding it.It names Lord Falconer, once Tony Blair's flatmate and in June 2003 appointed Lord Chancellor, as the architect of the public inquiry into Dr Kelly's death chaired by Lord Hutton.
It was Falconer who proposed the controversial decision to abandon a coroner's inquest, where witnesses would be cross-examined under oath, and replace it with a non-statutory examination of the circumstances leading to Dr Kelly's death. As a result no witness, including Tony Blair and his press secretary Alastair Campbell, swore an oath or was cross-examined...
The memorial addresses - and answers - each of the six legal points necessary for a coroner's inquest to be re-opened. Under section 13 of the Coroners Act 1988 only one of these points has to be satisfied for an inquest to take place.
The 10,000-word document was co-authored by doctors Stephen Frost, Martin Birnstingl, Christopher Burns-Cox, David Halpin and Andrew Rouse...

Saturday, December 11, 2010

FBI interferes with release of NAS report on the scientific aspects of the Amerithrax case

As I told the audience at the Anthrax Letters Seminar on November 29,
Please remember that the FBI “owns” the narrative of this case.  It has released piecemeal findings, contradictory facts, and withheld a large amount of information from the public record... 
Most important, the facts of this case (as opposed to what the FBI has released in a controlled fashion) have never been contested and established in a court of law.
 FBI's newest gambit is intended to reshape the (FBI-purchased) National Academy of Sciences study of FBI's science (FBI clearly wasn't happy with the almost-published report it was given to review), as FBI tries to retain control of the anthrax letters narrative.

According to Yudhijit Bhattacharjee at Science magazine,
The FBI has belatedly provided an expert panel with new information that will delay a long-awaited report on the scientific merits of the government's investigation into the deadly 2001 anthrax mailings...  The academy panel submitted the report to the FBI on 27 October. On 3 December, FBI officials provided new material and asked for an opportunity to make a presentation before the committee.
According to Greg Gordon at McClatchy,
A New Jersey congressman has called the request "disturbing" and asked the FBI for an explanation. 
In a letter to FBI Director Robert Mueller Thursday, Democratic Rep. Rush Holt said that it appears that the FBI "may be seeking to try to steer or otherwise pressure the NAS panel to reach a conclusion desired by the bureau." 
Holt, a scientist and the chairman of the House Select Intelligence Oversight Panel, said the academy recently shared with the bureau its draft report on the "Amerithrax" investigation, a narrow scientific review that the FBI requested in 2008 in an effort to quell controversy over its findings that a disgruntled government scientist was behind the attacks. 
"This week I was informed by the NAS that the FBI would be releasing an additional 500 pages of previously undisclosed investigative material from the Amerithrax investigation to the NAS," he wrote. Holt said he understands that the "document dump . . . is intended to contest and challenge the independent NAS panel's draft findings."
"If these new documents were relevant to the NAS' review, why were they previously undisclosed and withheld?" Holt wrote. He requested a meeting with the FBI director...
 According to Megan Eckstein at the Frederick NewsPost,
The FBI's move came as a surprise to the academy. Spokeswoman Jennifer Walsh said on Nov. 30 the committee was finalizing its report for the upcoming release, and in a Dec. 10 e-mail she wrote "at that time we didn't know we would receive any relevant information.
"We were surprised given our prior request for all relevant information," she said. "Some, but not all, of what the FBI has now turned over is relevant to the committee's charge, and they are the type of materials we requested previously. However, I can't characterize what types of materials they are."
Information on Congressman Holt's response to the latest FBI trick and his letter to FBI Director Mueller can be found here.

Tuesday, December 7, 2010

David Kelly: No fingerprints on tablets in his pocket or knife he supposedly used to commit suicide/ Daily Mail

Calls for an inquest are made anew as lack of fingerprints on the two items supposedly used to commit suicide, (3 packs of ten Co-proxamol [Darvon plus Tylenol] tablets and a pruning knife) becomes public knowledge.

Note that blood levels of Darvon and Tylenol were therapeutic, and did not support any overdose.  Why Kelly would choose a pruning knife instead of a razor blade is another question, especially since the knife had no fingerprints on it and there were no gloves at the death scene.

This case is as ridiculous as the case against Ivins for the anthrax letters.  For Kelly there was no inquest, either--and the doctor who performed the autopsy, Nicholas Hunt, missed major findings, claiming the "overdose" that wasn't one contributed to Kelly's death.
From the Daily Mail:
Fresh doubts have been raised over how Dr David Kelly died after police admitted no fingerprints were found on the packs of pills he supposedly overdosed on...

Sunday, December 5, 2010

Influenza vaccine clinical trials: reliable evidence is thin, but there is evidence of widespread manipulation of conclusions/ Cochrane

A 2010 update to Cochrane's 2007 metaanalysis of the published clinical trial literature on influenza vaccinations found not a lot to recommend the vaccines.  Cochrane pointed out, "Healthy adults are presently targeted mainly in North America."  The implication is that Europe, where most reviewers reside, is too smart to push mass flu shots on its healthy population.
In the relatively uncommon circumstance of vaccine matching the viral circulating strain and high circulation, 4% of unvaccinated people versus 1% of vaccinated people developed influenza symptoms (risk difference (RD) 3%, 95% confidence interval (CI) 2% to 5%)...  Vaccination had a modest effect on time off work and had no effect on hospital admissions or complication rates. Inactivated vaccines caused local harms and an estimated 1.6 additional cases of Guillain-Barré Syndrome per million vaccinations. The harms evidence base is limited.
CONCLUSIONS: Influenza vaccines have a modest effect in reducing influenza symptoms and working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission.WARNING: This review includes 15 out of 36 trials funded by industry (four had no funding declaration). An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in light of this finding.

Saturday, December 4, 2010

Military Contractors Were Granted Legal Indemnity for Hazardous Substances (including anthrax vaccine)/ NY Times

The manufacturer of the only licensed anthrax vaccine (Emergent Biosolutions, a.k.a. Bioport) purchased the company from the state of Michigan in September 1998 immediately after the Army promised to indemnify the company (provide a free insurance policy) against claims for side effects, lack of efficacy and other potential problems.

The language in the contract was questioned at the time, as the vaccine manufacturer received indemnification protection as if it were doing far more hazardous work than simply making a vaccine.  And it was the taxpayer that would foot any bills.

Now we find that the taxpayer did pay:
Several high-profile military contractors pushed for and won legal indemnity from the Pentagon before starting projects that involved exposure to chemical weapons and other highly hazardous substances, according to documents released yesterday by Rep. Earl Blumenauer (D-Ore.).
The data uncovered by Blumenauer shows that the Pentagon paid legal bills for at least one firm that invoked its indemnity provisions. Emergent BioDefense Operations Lansing Inc., manufacturer of an anthrax vaccine widely used by the military, was reimbursed for nearly $650,000 after billing the Army for more than $1.5 million in 2008.
The original Pentagon memo granting indemnity to Emergent described, as did the KBR contracts that prompted the National Guardsmen's lawsuits, the nature of the "unusually hazardous" risks facing the biotechnology company.
"Production and testing of [the anthrax vaccine] require interaction with one of the most lethal biological agents known to man," the November 2000 memo stated, providing for an indemnity claim by Emergent in case of the "release (or alleged release) of an infectious agent or toxic chemical into the environment in connection with" work required by the contract...
UPDATE May 26, 2011:  From the Oregonian, snippets:
Oregonians on Wednesday successfully amended the House Defense Authorization bill to spotlight who pays when a defense contractor causes harm.

The amendment requires the Pentagon to report when it enters or changes immunity agreements with contractors. It is the latest strategy by U.S. Reps. Earl Blumenauer and Kurt Schrader to boost the transparency into defense contracts... 

Blumenauer sought to get a copy of the indemnification clause in the KBR contract, which remains classified. But Blumenauer was able to make public 124 contracts with similar immunity provisions from the Pentagon. The list indicated the government legally covers dozens of military contractors doing dangerous jobs, such as making anthrax vaccine or disposing of mustard gas...

Tuesday, November 30, 2010


This was my presentation to the University of California Institute on Global Conflicts and Cooperation seminar on the anthrax letters, Nov. 29, 2010 in Washington, D.C. 

DVDs with the full video recording of the anthrax seminar can be purchased at cost ($12) from



I was acquainted with Bruce Ivins from 1991 until his death.  Yes, he had significant emotional problems and was socially awkward.  However, his scientific work was of high quality and was relied on by those studying anthrax vaccines here and abroad. 

Bruce sought neither money nor fame.  He could have used his expertise to consult at a much higher salary, especially after the anthrax letters were sent, but chose not to.  At work, he was invariably generous and helpful to others, myself included.

There was absolutely no risk of Bruce losing access to anthrax vaccine and thereby becoming unable to do his research, as FBI claims in its attempt to create a credible motive for the crime.  USAMRIID, the Army research center where Bruce worked, holds dozens of unlicensed vaccine candidates, including those for anthrax, which researchers routinely use to vaccinate themselves.  Researchers at USAMRIID always have vaccines available for their own use, licensed or not.

The FBI wrongly claimed that the work of myself and others -- “a chorus of critics” -- questioning the safety and efficacy of anthrax vaccine and its role in Gulf War Syndrome threatened Bruce, contributing to his disturbed state of mind at the time the letters were sent. 

In fact, Bruce also questioned the quality of the licensed anthrax vaccine, and gave me a number of articles and abstracts over 10 years that raised questions about both the vaccine’s safety and efficacy.

In fact, the anthrax vaccine manufacturer had been shut down by FDA for two years when the letters were sent, due to repeated failures to meet good manufacturing practices.   Had Bioport (now Emergent Biosolutions) remained shut down, Bruce’s vaccines might have been the next generation used to inoculate troops.  The anthrax letters breathed new life into the Bioport vaccine, not into Bruce’s vaccines.

In fact, studies Bruce performed in 1991, in which vaccinated monkeys were later exposed to inhaled anthrax, resulted in the vaccinated monkeys coming down with anthrax despite their vaccinations, though the majority eventually recovered. (See page 41 of FBI’s 2/19/2010 report.)  No one understood the serious inadequacies of the currently licensed vaccine better than Bruce.

Recall that FBI tried to close this case on August 1, 2008, 3 days after Bruce’s death.  The FBI orchestrated a crescendo of leaks about Bruce over several days, full of lurid details that aimed to create a picture of a “lone nut” for the American public.  Much of this material was inaccurate or exaggerated, and FBI officially apologized for the leaks later.

Apologies aside, this was a tawdry attempt to bury one of the most important cases the FBI has ever investigated, both because of its national policy implications and the huge effort, time and money consumed by the investigation.  Remember that the anthrax letters helped pave the way for passage of the USA Patriot Act, for going to war with Iraq (although Iraq was not a credible suspect in the 9/11 attacks, everyone knew it had stockpiled anthrax) and for expansion of the federal biodefense budget to 50 billion dollars and counting.

Were aspects of Bruce’s death orchestrated as well?  Although the anthrax letters case was one of the FBI’s biggest ever, Bruce’s death somehow didn’t warrant an autopsy or an inquest.

Bruce purchased two bottles of Tylenol PM, during 2 separate trips to the same store, on July 24, 2008.  Tylenol PM is an over the counter sleep aid, consisting of Tylenol and Benadryl.

At 1 am on July 27 Bruce was reported to be in a coma due to liver failure.  He was brought to the hospital by ambulance, and on July 29 he died. 

It takes from 2 to several days for liver failure to occur after ingesting a large dose of Tylenol.  A very effective antidote exists, which provides substrate so the body can detoxify the lethal substance formed as Tylenol is metabolized.  This antidote, either N-acetyl cysteine or alternatively glutathione, will save the patient’s life if given within about 24 hours of an otherwise lethal Tylenol ingestion.

     3d slide – Tylenol poisoning, Merck Manual

As you can see from the Merck Manual, mortality from a Tylenol overdose is extremely rare when this safe, easily available treatment is given in a timely manner.

Bruce was under intensive, 24/7 surveillance by the FBI near the end of his life.  The FBI almost certainly knew Bruce purchased a large amount of Tylenol on July 24, and probably also knew when he ingested it, and when he developed symptoms and eventually coma.

I have seen no report or evidence that the FBI informed anyone, especially Bruce’s medical providers, of his Tylenol ingestion.   Doing so in a timely manner would have almost certainly saved Bruce’s life and allowed the FBI to bring its case against him to its legal conclusion. Nor did FBI intervene to hasten Bruce receiving medical attention after his ingestion.

Was the FBI’s case against Bruce too weak to withstand a trial?

Was Bruce’s death a precondition for closing the case?


Moving on, I’d like to mention some examples of how the 2/19/2010 FBI report misleads and overreaches.  How can the FBI explain the following missteps?

1.    FBI sent a letter to Bruce in April 2007, stating that he was not a target of the investigation.
2.    Why was no DNA obtained from Bruce until the week before his death?
3.    Why did Bruce retain his security clearance until 19 days before his death?
4.    FBI has failed to find evidence placing Bruce in New Jersey where the letters were mailed.
5.    FBI has failed to show how Bruce could have been at the mailbox during the window of time in which the letters were sent.
6.    FBI failed to find any anthrax contamination in Bruce’s car, home or possessions, although the simple act of placing a letter in the mailbox would have led to massive spore contamination of everything in the area, including the mailer. (See paper by FBI’s Doug Beecher)
7.    FBI’s February 2010 report tries to have it both ways.  It claims that flask RMR1029 was under Bruce’s exclusive control between its 1997 creation and the anthrax letter attacks.  The report claims that “only a very limited number of individuals had access” to the flask.  Later it admits that approximately 400 people at USAMRIID and a Midwest contractor laboratory had access to the spores.
8.    FBI claims Bruce had the know-how to produce the weaponized spores found in the Leahy-Daschle letters.  But FBI itself has failed to reverse engineer the spore production method, does not know what that method entails, and therefore cannot possibly know if Bruce had either the knowledge or access to all the equipment needed to produce such spores.
9.    FBI has failed to find any trace of the strain of Bacillus subtilis that contaminated the anthrax spores in the first set of letters, at USAMRIID or anywhere else.  Had the contaminated batch of anthrax been made at USAMRIID, the Bacillus subtilis strain would have contaminated the work space and been identified.
10.    FBI claims it ruled out 400 people who had access to the spores, but fails to explain anything about the processes used to rule these people out.
11.    Bruce passed two FBI polygraph tests, but later FBI claimed he used “classic” countermeasures to thwart the polygraphs.  Experts dispute this FBI claim.
12.    FBI’s report claims Bruce had access to a photocopier, but fails to note it was not the copier used to produce the anthrax letters.
13.    FBI initially reported that the water the spores were grown in came from the Frederick, Maryland area.  FBI later backed off this claim.
14.    FBI initially said that minor deviations in the pre-franked envelopes used for the anthrax letters showed they were purchased from the Frederick, Maryland post office.  Later FBI acknowledged they were sold widely in Maryland and Virginia.
15.    Nowhere in the February 2010 FBI report is there any acknowledgment that the crime could have involved more than one person.  Yet in my opinion, the logistics are such that it is almost a certainty more than one person was involved.
16.    The FBI obtained nearly all its 1,000 anthrax samples voluntarily from labs in the US and abroad.  This assumed that the anthrax mailer fully complied with the FBI request, even though it might incriminate him.  I’d call this a risky assumption, which undermines the foundation of the FBI’s entire case.
17.    FBI’s report postulates that two one-week windows of opportunity existed in which each batch of anthrax letter spores could have been grown, processed and mailed.  The time period for the first set of letters was September 11 through 18, 2001.  The period for the second set was October 1 through 8, 2001 (see page 6 of the FBI report).  FBI therefore reported focusing its investigation on individuals who had access to flask RMR 1029 and an anthrax “hot room” (a.k.a. BL 3 or 4 high containment laboratory) during these periods, in its attempt to identify and investigate all potential perpetrators.

However, there are several problems with this assumption.  First, the US government did not know how many high containment labs existed in the US and abroad in 2001, as they did not have to be registered or inspected.  Some may have belonged to private companies or individuals.

Second, although the anthrax letters were mailed during short windows of time, and the text included with the letters was probably written shortly before mailing, there is no reason to think that the spores had to be grown and processed during these periods. 

Since the FBI was unable to duplicate the process used to produce the spores, it is uncertain whether production in a particular lab could be completed during a one-week period.

Spore production and processing could have taken place considerably earlier, and/or the spores might have been supplied to the mailer by another person. 

Dealing with such considerations would have increased the complexity of the FBI’s case, and dramatically increased the universe of potential suspects.  FBI decided not to investigate these likely scenarios.

Please remember that the FBI “owns” the narrative of this case.  It has released piecemeal findings, contradictory facts, and withheld a large amount of information from the public record.  Much of the material provided to the media has been given without attribution, so there is no one at FBI to query about the information. 

Most important, the facts of this case (as opposed to what the FBI has released in a controlled fashion) have never been contested and   established in a court of law.


The FBI worked hard to develop a theory of this case that provides the needed justifications for Bruce to have committed this crime.

The FBI discussion of means, motive and opportunity sounds plausible at first look, but fails on more pointed inquiry.  I have discussed much of this already, but would like to make clear that FBI has yet to demonstrate that Bruce Ivins had any of the elements required to commit this crime.

Did he have the means?  He lacked the Bacillus subtilis contaminant found in the first letters. Since the spore preparation method remains unknown to the FBI, it is impossible to know if Bruce had access to the materials, equipment and knowledge to produce these spores.

Did he have a motive?  None of the FBI’s purported motives is in conformance with the known facts of Bruce Ivins’ career.

Did he have the opportunity?  The scenario initially floated by the FBI to claim that Bruce could have driven to New Jersey and back to mail the letters was shot down, and no new information has been provided by the FBI in support of Bruce’s ability to do so.

MICROBIAL FORENSICS and the National Academy of Science panel

The FBI reported working with over 60 scientists at 29 laboratories to develop new techniques that allowed it to identify the source from which the anthrax letter spores were grown.  This shiny new science is what the FBI hopes to hang its case on.

FBI has further sought the imprimatur (“seal of approval”) of the National Academy of Sciences (NAS) for its new scientific techniques.

The scientific minutiae of this body of work are so complex that FBI expects the public to get lost in the details, and fail to see the woods for the trees.

For scientific work to be accepted by the scientific community, it has to meet a number of criteria.  The research much be:

a) conceptually valid
b) accurate in its execution
c) fully reproducible
d) published and accepted by other scientists in the field

The microbial forensics work commissioned by the FBI for this case has yet to demonstrate that it meets any of these criteria.  We know very little about this research.   

Despite the FBI’s Dr. Majidi saying in August 2008 that independent scientists would now publish their work on the case, a Pub Med (National Library of Medicine) search using the search terms ‘anthrax’ and ‘letters’ revealed not a single published paper describing the FBI studies since then.

The National Academy of Science panel will issue its report on the FBI’s microbial forensics soon.  But given the lack of information available for evaluation in the open literature, the NAS panel is handicapped by its overwhelming reliance on briefings by the FBI and its contracted scientists.  Until the standard procedures of peer review described above are completed, it will be very difficult to determine the validity and usefulness of the FBI’s research.

But in any event, the microbial forensics can play only a limited role in solving this crime.  Even if the FBI’s scientific work is found to be entirely reliable, it can only identify the source spores from which the anthrax letter spores were grown.  The studies are unable to implicate any one individual as the perpetrator. 

In order to identify the person or persons involved, old-fashioned investigative techniques are needed, and hard evidence.  But such techniques failed to find any direct evidence linking Bruce to the crime.  Instead, we have been entertained with a colorful and varied pastiche of circumstantial evidence proving that Bruce had unusual habits, psychological problems, and was increasingly disturbed in the period leading to his death.

Tuesday, November 23, 2010

Taliban leader in secret talks was an imposter--"And we gave him a lot of money"/ NY Times

From the war that never ends, has no endgame, in the country that destroys empires comes this little item courtesy of the NY Times.  We can't even identify the enemy's leaders to negotiate with!  But we can and do give them large chunks of money...
KABUL, Afghanistan — For months, the secret talks unfolding between Taliban and Afghan leaders to end the war appeared to be showing promise, if only because of the appearance of a certain insurgent leader at one end of the table: Mullah Akhtar Muhammad Mansour, one of the most senior commanders in the Taliban movement.
But now, it turns out, Mr. Mansour was apparently not Mr. Mansour at all. In an episode that could have been lifted from a spy novel, United States and Afghan officials now say the Afghan man was an impostor, and high-level discussions conducted with the assistance of NATO appear to have achieved little.
“It’s not him,” said a Western diplomat in Kabul intimately involved in the discussions. “And we gave him a lot of money...”

Friday, November 19, 2010

National Research Council pans government studies of safety of multiple proposed biodefense labs/ Science

Like so much in today's world of politics, there is no logic that can explain it.  Biodefense labs (whose value in the light of the risk they pose is questionable) are being built smack in the middle of large cities (Boston), in areas that flood (Galveston), and in the middle of a farming area dense with livestock (Manhattan, Kansas). 

Luckily the National Academy of Science's National Research Council has gone on record to point out some of the obvious anomalies.  Two recent stories in Science magazine are worth a look.

From Science, Nov. 18:
Federal officials are still stumbling in their efforts to analyze the risks of operating a high-security biology lab in Boston that would study dangerous pathogens such as Ebola virus and anthrax, says the National Research Council (NRC).
The National Institutes of Health (NIH) awarded the $128 million lab to Boston University in 2003; the building is complete but not yet operating. But the university's plan to use part of the building to study the deadliest pathogens in biosafety level-4 (BSL-4) facilities has drawn fierce opposition from the local community. An NRC panel stoked those concerns in 2007 when it panned NIH's risk assessment. NIH started over.
But in a report released today, the same NRC panel says it "cannot endorse as scientifically and technically sound the illustrative analyses presented" by contractors conducting the new assessment.
The report says that the contractors ignored NRC's advice to first qualitatively assess the risks of 13 different pathogens, then quantify risks for a subset. Instead, the contractors forged ahead with modeling risks for all 13 pathogens by using expert opinion instead of actual data and information from case studies. The NRC report recommends a "mid-course correction."
The critique comes the same week that a different NRC panel found problems with a risk assessment for a huge federal agricultural biodefense lab planned for Kansas.
From Science, Nov. 15:
An expert panel today harshly criticized a federal study of the risks of building a giant new lab in Kansas to study the world's most dangerous animal pathogens. The report from the U.S. National Academies' National Research Council (NRC) says a risk assessment by the Department of Homeland Security (DHS) has "several major shortcomings," including inadequate data for predicting the economic impact if highly contagious foot and mouth disease (FMD) virus were accidentally released and infected U.S. cattle.
DHS announced in 2005 that it planned to replace the old Plum Island Animal Disease Center off Long Island with a facility on the U.S. mainland to study FMD and even more dangerous pathogens, such as Nipah virus. DHS considered six sites for the $450 million lab, and in late 2008 announced that it has chosen Manhattan, Kansas, to host the National Bio- and Agro-Defense Facility (NBAF). But last year, a U.S. Government Accountability Office (GAO) slammed DHS's risk assessment for the Kansas site as inadequate. Congress withheld construction funding until DHS redid the assessment and had it reviewed by the National Academies...
But the panel found many problems with the new DHS assessment, completed in June. Based on data in the DHS report, the NRC panel estimated that there is a 70% chance over 50 years that FMD would escape from the lab and infect livestock, resulting in an economic impact of between $9 billion and $50 billion. But while DHS came to "many legitimate conclusions," the NRC panel found, its analysis "is not entirely adequate or valid..."

Thursday, November 18, 2010

37 narcolepsy cases in Finnish children developed after swine flu vaccinations/ YLE

From YLE print and TV in Finland:
...  Thirty-seven children in Finland came down with narcolepsy soon after being injected with the vaccine against swine flu.
Some of the children have sustained serious brain damage that has made it impossible for them to attend school. They suffer from symptoms including hallucinations, personality changes and cataplexy, which is a severe muscle weakness that can lead to a complete collapse up to 20 -30 times a day.
The Chancellor of Justice has received 14 complaints regarding ties between GlaxoSmithKline (GSK), the manufacturer of the swine flu vaccine, and the National Institute for Health and Welfare (THL)...  The Finnish National Institute for Health and Welfare (THL ) maintains that cooperation with pharmaceutical companies is standard practice for professional organisations.

Wednesday, November 17, 2010

Ahmed Ghailani, Gitmo detainee, acquitted of all but 1 charge in NY/ WaPo

Military tribunals (and places like Guantanama) for so-called terrorists transgress the 5th, 6th, 8th and 9th Amendments of the Constitution's Bill of Rights.   Goodbye to Habeas Corpus, Due Process and Geneva Convention protections, among others.  Olbermann provided amusing commentary

But we can't get convictions using real courts, real judges and real juries.  What a dilemma!  We must convict, after all, right?

From the Washington Post:
The failure to convict Ghailani, a native of Tanzania, on the most serious terrorism charges will bolster the arguments of those who say the military prison at Guantanamo Bay, Cuba, should be kept open, both to host military commissions for some prisoners and to hold others indefinitely and without trial under the laws of war...
"One of 285 counts is not exactly a track record for a prosecution team to be proud of," said Kirk Lippold, former commander of the USS Cole, which was attacked by al-Qaeda in 2000. "I think the administration is now in a position where they have to get serious about using military commissions. This case sends a clear and unmistakable signal about using civilian courts: It didn't work." 
Excuse me?  What laws of war are these exactly?  Who precisely are we at war with?  Who aren't we at war with?  Didn't we illegally kidnap these people (our Guantanamo defendants) and secretly abduct them to Guantanamo, so they would not be subject to the laws of any nation?  What is this #$%^&* about the "laws of war"?  Stephen Rohde and Daphne Eviatar were even more upset about all this than I am, and documented the reasons much better than I could.

UPDATE:  Attorney Glenn Greenwald shines his laser spotlight on this case here.

IMHO, without the rule of law this country is nothing.  If you trash the Constitution, what is left that makes us in any way better than any other country, if not decidedly worse?

HPV Vaccine: only about 30% of young women who start the series complete it

Two articles, each reporting on a different study, found that uptake of subsequent doses of HPV vaccine, after the first, was poor.  Neither entertained the possibility that side effects might have something to do with this.  Maybe side effects had nothing to do with it.  But since vaccine effectiveness depends on 3 repeated doses, it makes little sense to start the 3-inoculation course and stop midstream.  Here and here the studies are discussed.

Sunday, November 14, 2010

David Kelly did not overdose; consider murder instead/ Daily Mail

Although a drug overdose was claimed to be a contributor to the death of Dr. David Kelly, a pharmacologist claims that Kelly did not have an elevated blood level of co-proxamol at the time of death.  This drug contained darvon and a "regular strength" tylenol, from which it would be very hard to overdose without many dozens of tablets.

Wednesday, November 10, 2010

Former BMJ editor spells out irresistable conflict of interest for medical journal editors/ BMJ Blog

From the BMJ blog comes this gratifying discussion of an important paper in the PLOS:
... an important and fascinating paper in PloS Medicine shows how editors can be exposed to dramatic conflicts of interest. 
The paper is suitably po faced, as is the accompanying editorial, but, as a blogger and ex-editor, I can spell out one of the conflicts of editors in stark terms. It arises when considering a large clinical trial funded by a drug company, and, for example, a third of the trials in the New England Journal of Medicine are funded by industry with almost another half having mixed funding that includes a drug company. Editors know well that they may be able to sell a million dollars worth of reprints of such an article, with a profit margin of perhaps 70%. In other words publishing that one paper will lead to $700 000 on the bottom line. Very few actions in business provide such a substantial profit from so little.

... As the paper in PloS Medicine shows, the New England Journal of Medicine in 2005-6 published 66 trials supported solely by industry and another 95 with some industry funding.

... It’s thus very tempting to publish that drug company sponsored trial, and the temptation is increased further by such trials boosting impact factors, as the PloS Medicine paper shows. Such trials are well cited partly because they are important and partly because drug companies have considerable resources to promote the papers, not least by distributing hundreds of thousands of reprints. The PloS Medicine authors calculate that the impact factor of the New England Journal of Medicine would be reduced by about 15% if it declined to publish drug company sponsored trials.

The PloS Medicine authors show, as have others, that the proportion of trials funded solely by industry ranges from 7% in the BMJ through 26% for JAMA to 32% for the New England Journal of Medicine.
... Ex-NEJM editor Marcia Angell was quoted by Smith, having written, “it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.” 

Changes to Program: The Anthrax Mailings Investigation, Nov. 29, 2010

The University of California Institute on Global Conflict and Cooperation (IGCC) and The UC Washington Center
Cordially invite you to attend a seminar:

The Anthrax Mailings Investigation

Monday, November 29, 2010, 1:00 – 5:30 pm

UC Washington Center, 1608 Rhode Island Ave. NW

FBI has closed the 2001 anthrax mailings investigation.  The alleged preparer and mailer of the anthrax, U.S. Army scientist Bruce Ivins, committed suicide, so the case was never tried in court.
A group of experts (see agenda below) assembled by Kenneth Dillon at Scientia Press and UCLA-based researchers Dr. Peter Katona and Prof. Michael Intriligator, will discuss the investigation, the scientific aspects, the lessons learned, and the broader implications of the case.  (Speaker bios are attached.)

Please RSVP, acceptances only, to Joseph R. McGhee at the IGCC Washington office:  Phone (202) 974-6295; Fax (202) 974-6299; email: .  For more on IGCC, see


1:00 pm:  Registration, coffee and tea
1:30 pm:  Introduction:  Peter Katona, UCLA, Master of Ceremonies
1:50 pm:  Panel I:  The Investigation
  • Moderator:  Lewis Weinstein, author, Case Closed
  • Ross Getman, author, Anthrax and al Qaeda
  • Paul Kemp, attorney of Bruce Ivins
  • Meryl Nass, Mount Desert Island Hospital,
3:30 pm:  Break
3:45 pm:  Panel II:  Lessons Learned and Broader Implications
  • Michael Intriligator, UCLA
  • Peter Katona, UCLA
  • Leonard Cole, Rutgers University, author, The Anthrax Letters
5:00 pm:  End

Leonard A. Cole is an expert on bioterrorism and terror medicine.  He is an adjunct professor in the Division of Global Affairs at Rutgers University, Newark, NJ.  Trained in the health sciences and public policy, he holds a Ph.D in political science from Columbia University, and a doctorate from the University of Pennsylvania School of Dental Medicine.  Cole has written numerous articles for professional journals and general publications.  He has lectured widely and made invited presentations to several government agencies including the U.S. Department of Energy, the Department of Defense, the Centers for Disease Control and Prevention, and the Office of Technology Assessment.  He is the author or editor of nine books, including Terror:  How Israel Has Coped and What America Can Learn (2007), Essentials of Terror Medicine (co-editor, 2009), and The Anthrax Letters (revised, 2009).
Kenneth J. Dillon is an historian and science writer.  He has a Ph.D in history from Cornell University and teaches a course in European history as an adjunct at Marymount University.  Dillon served 11 years as a foreign service officer, including as an intelligence analyst.  He has also worked as a medical device entrepreneur and currently has a scientific publishing business.  Dillon has written articles and books on history, science, and medicine; and he has made theoretical contributions in history and science.  His articles on the anthrax mailings case are at
Ross Getman graduated from Harvard Law School in 1984 where he was a member of the Law Review.  After working for Arnold & Porter, and Jones, Day, Reavis & Pogue in Washington, D.C., and living in Arlington for 15 years, he returned to his roots in Upstate New York.  In past years, in alliance with public interest groups and class action law firms, he advocated that soda should not be sold in public schools.  Separately, he represented a soda industry whistleblower that forced numerous recalls internationally relating to soft drinks that contained benzene and forced the reformulation of drinks worldwide.  Relying on industry lab testing, he caused recalls of bottled water in the Northeastern U.S. containing the carcinogen bromate.  Getman has closely followed the Amerithrax investigation since December 2001 and has written Anthrax and Al Qaeda:  Infiltration of US Biodefense.  The Washington Post credited Getman with first publicly identifying the Pakistani scientist Rauf Ahmad with helping Ayman Zawahiri in his plan to develop anthrax as a weapon.
Michael D. Intriligator, Ph.D is Professor Emeritus of Economics and Professor of Political Science, Professor of Public Policy, and Co-Director of the Jacob Marschak Interdisciplinary Colloquium on Mathematics in the Behavioral Sciences at UCLA.  He is also a Senior Fellow of the Milken Institute.  He has taught economic theory, econometrics, mathematical economics, international relations, and health economics; and he has received several distinguished teaching awards.  Intriligator is the author of more than 200 journal articles and other publications in economic theory and mathematical economics, econometrics, health economics, reform of the Russian economy, and strategy and arms control, his principal research fields.  He has authored or edited many books in economics and international relations.  Intriligator is Vice Chair of Economists for Peace & Security and past president of the Peace Science Society (International) and Western Economic Association International.  Intriligator is a member of the Council on Foreign Relations and the International Institute for Strategic Studies, and is listed in Who’s Who in America, Who’s Who in the World, and Who’s Who in Economics.  He co-teaches a terrorism seminar and has co-edited Countering Terrorism and WMD (2006) and Global Biosecurity:  Threats and Responses (2010).
Peter Katona, MD is Associate Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA in Infectious Diseases.  He has worked at the Centers for Disease Control and Prevention and for Apria Healthcare as the corporate medical director.  Katona has been a consultant to the Los Angeles County Department of Health Services on the development of an information management system geared toward biological terrorism preparedness (known as the Health Alert Network) and as medical consultant to the county Emergency Medical Services Agency.  He is co-founder of Biological Threat Mitigation, a bio-terror consulting firm and has an active infectious disease practice at UCLA.  Katona is co-editor of Countering Terrorism and WMD (2006) and  Global Biosecurity:  Threats and Responses (2010).
Paul F. Kemp, JD has practiced law in Maryland since 1974 and in the District of Columbia since 1976.  Kemp is a fellow of the American College of Trial Lawyers.  He focuses his practice on litigation in the state and federal courts, primarily in the area of white-collar crime and general criminal practice.  For white collar criminal defense, Kemp has been cited in The Best Lawyers in America; Maryland Super Lawyers “Top 50″ Attorneys lists, and D.C. Super Lawyers “Top 50″ Attorneys lists.   In 2002, Washingtonian named Kemp one of its “Top Seventy Five Lawyers” in the Washington area.  Prior to entering private practice, Kemp served as an Assistant State Public Defender with the Maryland Public Defender’s Office, an Assistant State Attorney with the Office of the Maryland Attorney General and Deputy Federal Public Defender, United States Department of Justice, District of Maryland.  During the “Amerithrax” investigation, Kemp represented Bruce Ivins from May, 2007 until his death on July 29, 2008.
Meryl Nass, MD has a varied career practicing inpatient internal medicine, running an outpatient clinic for complex disorders, investigating epidemics, and blogging.  She identified the world’s largest epidemic of anthrax (affecting over 10,000 Rhodesians in 1980) as a biological warfare event in 1992 based on careful analysis of its different features; diagnosed Cuba’s 1993 neuropathy epidemic as due to a combination of cyanide exposure and nutritional deficiency; investigated the safety and efficacy of anthrax vaccine; and has discussed both the scientific and investigative features of the anthrax letters case.  Nass has testified before 3 Congressional committees and provided requested testimony to 4 additional hearings on bioterrorism, anthrax vaccine, and Gulf War Syndrome.  Nass may be the only person who has consulted both for the Cuban Ministry of Health and the Director of National Intelligence.  Her blog is an important source for discussion of the anthrax case.
Lewis M. Weinstein has had a career that included top management posts in the private, public, and not-for-profit sectors.  Most recently, he was for 15 years the CEO of the Public Health Research Institute, an organization specializing in sophisticated infectious disease research.  In 1980, he was candidate for U.S. Congress.  Lew received an undergraduate degree in engineering from Princeton University and an MBA from the Harvard Business School.  Since retiring in 2005, Lew has become a fulltime author.  His third novel, CASE CLOSED, is about the 2001 anthrax attacks and the subsequent FBI investigation.  His CASE CLOSED blog ( has become one of the primary sources for information and discussion of the anthrax case.  It is Lew’s view that the FBI has either not solved the case or is withholding crucial aspects of what really happened.

Monday, November 1, 2010

Surveillance for vaccine adverse effects is inadequte/ Medical Journal of Australia editorial

From Sydney Morning Herald and Medical Journal of Australia:
The [following] editorial calls for the urgent establishment of a new national body to provide uniform monitoring and "active surveillance", looking for adverse reaction cases in the community.
"This is critical to ensure that the benefits of vaccination outweigh the risks," Dr Gold said.
Passive surveillance cannot be relied on as the sole means of surveillance

Michael S Gold, Paul Effler, Heath Kelly, Peter C Richmond and Jim P Buttery

492 MJA• Volume 193 Number 9 • 1 November 2010


On 22 April 2010, use of seasonal trivalent influenza
vaccine in children aged 5 years and under was suspended
across Australia, pending an investigation into an appar-
ent increase in reports of adverse events following immunisation
(AEFI).1 This unprecedented halt to a national immunisation
initiative followed Western Australia’s decision to place a mora-
torium on the use of this vaccine in young children after observing
a spike in emergency department presentations for high fever and
febrile convulsions after vaccination.2 A subsequent investigation
by the Therapeutic Goods Administration indicated that febrile
convulsions related to the vaccine were reported from all jurisdic-
tions except the Northern Territory.2 The apparent rate of febrile
convulsions following vaccination was 5–9 per 1000 doses admin-
istered, about 50 times higher than that reported following
measles–mumps–rubella vaccination
.2,3 A recent review, requested
by the Minister for Health in WA, has highlighted significant
deficiencies in AEFI surveillance
In Australia, the current mechanism for identifying AEFI nation-
ally is passive surveillance. Passive surveillance relies on health
providers and the public recognising and reporting suspected
AEFI to state or federal health authorities. The constraints that are
inherent to passive surveillance, including under-reporting and
biased reporting, are compounded by the diverse approaches to
surveillance that are employed throughout Australia, as illustrated
by a fourfold difference in AEFI reporting rates per 100000
population between jurisdictions.
5,6 Adding to concerns about
variable sensitivity across the state systems is the inevitable delay
in collection, aggregation and analysis of AEFI reports forwarded
to the national authority.
A number of the issues evident during the response to the
vaccine-associated reactions were recognised 5 years earlier during
the National Vaccine Safety Workshop.7 A clear set of recommen-
dations for improving adverse event surveillance was identified at
the time, but many of the recommendations have not been
adequately addressed.

Robust postmarketing surveillance is vital for influenza vaccines
because seasonal trivalent influenza vaccine does not require
clinical trial data to demonstrate safety before release
— it is
assumed that safety is not altered by the annual change in the
combination of vaccine strains.
While past experience suggests
that this is true, history also indicates that future vaccine scares are
inevitable and we should plan accordingly.8 Trivalent influenza
vaccine, in particular, highlights the need for postmarketing
surveillance to be linked with the capacity for rapid review and
response, because a large proportion of the vaccine is administered
over a short period before the onset of the influenza season each
The way forward is to establish a coordinated, uniform approach
to AEFI reporting, coding, collation and analysis. A standing
vaccine safety monitoring group which includes key stakeholders
— representing the regulators, state and national immunisation
programs and vaccine safety and epidemiology experts — needs to
be urgently established.

The inability of the existing surveillance systems to detect the
early signal of an increased incidence of febrile convulsions, within
24 hours of receiving 2010 seasonal trivalent influenza vaccine,
demonstrates that passive surveillance cannot be relied on as the
sole means of surveillance. Complementary active surveillance
systems which can methodically detect potential AEFI signals,
quickly establish rates and establish causality should be devel-
oped. The Australian Childhood Immunisation Register is
uniquely placed to contribute to vaccine safety surveillance
through data linkage with hospital morbidity and emergency
department datasets, as demonstrated by a recent study from
South Australia.3 Sentinel surveillance in four tertiary care Austral-
ian paediatric hospitals has been shown to be an effective mech-
anism of surveillance for specific AEFI.9 Implementing active AEFI
surveillance systems will require sustainable funding, but this will
be a small fraction of the cost expended on vaccines and vaccine
delivery and could be resourced by levying a surcharge per vaccine
dose sold, similar to methods adopted elsewhere to support
compensation for vaccine-associated injuries.
Central to any system of vaccine safety monitoring are issues of
governance; specifically, transparency in decision making.
countries currently provide full disclosure and web access to de-
identified AEFI reports and open access to the deliberations of
expert committees.11,12 This engenders public trust in immunisa-
tion programs, and similar strategies should be considered in
The vast majority of Australian parents, vaccine recipients and
health care providers trust public health authorities to assess and
monitor vaccine safety. This is critical to ensure that the benefits of
vaccination outweigh any potential risks. In the aftermath of the
2010 seasonal trivalent influenza vaccine experience, maintaining
the public’s trust requires that we get started on building the fully
functional, standard-of-care AEFI surveillance system that Aus-
tralia deserves. Vaccine safety should be an integral component of
the National Immunisation Strategy, which should include strat-
egies for comprehensive and complementary passive and active
systems of surveillance.

For disclosures, footnotes and author information go here.