Tuesday, March 30, 2010

Gardasil: 49 US deaths reported to VAERS/ Washington Examiner

From the Washington Examiner
Cervical cancer accounts for less than 1 percent of all cancer deaths, so it was somewhat surprising when the U.S. Food and Drug Administration fast-tracked approval of Gardasil, a Merck vaccine targeting the human papilloma virus (HPV) that causes the disease, in 2006.
As of Jan. 31, 2010, 49 unexplained deaths following Gardasil injections have been reported to the Centers for Disease Control and Prevention's Vaccine Adverse Event Reporting System (http://vaers.hhs.gov/index). By contrast, 52 deaths are attributed to unintended acceleration in Toyotas, which triggered a $2 billion recall.
These are 49 deaths in healthy teens and young women, not the elderly.  These deaths cannot be balanced against lives saved by the HPV vaccine, because all those who receive it still have to have regular PAP tests.  For women who receive yearly PAPs, the death rate from cervical cancer approaches zero.

Why get PAPs once you are vaccinated?  Doesn't the vaccine prevent HPV infections?  The answer is that it does, sometimes.
  • It doesn't prevent infections from all HPV strains that can cause cancer.  
  • The vaccine effect is temporary, but we don't know exactly how long it will last.
  • No vaccine works 100% of the time, and how well this one works remains to be seen.  For example, the best flu vaccines provide immunity in at most 70% of recipients.
How did FDA respond to this information?  It approved the vaccine for boys as young as age nine to prevent venereal warts due to HPV!

Understandably, FDA can claim it approved this vaccine to prevent cancer in women; this is the first cancer vaccine approved in the US.  Getting it licensed  made a splash!  It also gave industry encouragement that FDA would look favorably upon other cancer vaccines in development.

But giving approval to this vaccine in boys, to prevent warts, when it appears to cause some healthy kids to die inexplicably--where is the logic in that??

Monday, March 29, 2010

CDC officials continue to urge H1N1 vaccination/ Infectious Disease News

Officials with the CDC are continuing to urge people to get the H1N1 vaccine, as a small uptick in H1N1 cases has been reported in the Southeast.
Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases said seasonal influenza activity is low this season, with H1N1 reported as the predominant strain. However, federal health officials are noticing a slight increase in cases in the Southeast, particularly in Georgia, where H1N1 vaccination rates are among some of the lowest in the country. Schuchat said 40 Georgia residents were hospitalized with laboratory-confirmed H1N1 in the past week...
Deaths from pneumonia and influenza are less than the epidemic threshold, Schuchat said.
No states are reporting widespread flu activity, and only three states — Alabama, Georgia and South Carolina — are reporting regional activity. 
 *  Yet in the US, cases are the lowest they have been overall since the 2009-10 flu season began last September -- Nass:

INFLUENZA Virus Isolated

Israel: Soldiers sue government over anthrax shots

From YNet News
Dozens of soldiers who took part in experiment in early 1990s aimed at determining efficacy of Anthrax vaccine demand $80,000 each in damages. 'Physical harm was passed down to our children,' plaintiff says.
There is no description in this article of the types of adverse reactions resulting from the vaccine, which may be a legal strategy, since there is not yet a consensus in the medical literature on what those reactions are.

Swine Flu Fallout

Today's Guardian discusses a draft report by UK MP Paul Flynn on the European response to the swine flu epidemic.  Titled "WHO accused of losing pubic confidence over flu pandemic," it includes the following:
In Britain, says Flynn, the discrepancy between the estimate of the numbers of people who would die from flu and the reality was dramatic. "In the United Kingdom, the Department of Health initially announced that around 65,000 deaths were to be expected. In the meantime, by the start of 2010, this estimate was downgraded to only 1,000 fatalities. By January 2010, fewer than 5,000 persons had been registered as having caught the disease and about 360 deaths had been noted," says his report.
The public health minister, Gillian Merron, told Flynn in a meeting for the report that a Cabinet Office investigation was looking into Britain's handling of the outbreak and would report some time after June. Countries across Europe reacted very differently to the pandemic, says the report. Not all mounted high-profile vaccination campaigns, as did the UK.
Flynn's draft accuses the WHO of a lack of transparency. Some members of its advisory groups are flu experts who have also received funding, especially for research projects, from pharmaceutical companies making drugs and vaccines against flu...
Meanwhile, a Reuters article reports that WHO will have its handling of the Swine Flu epidemic reviewed by a panel of independent experts selected by WHO:
"A group of independent experts will review how the H1N1 pandemic has been handled to ensure that the next global health emergency is dealt with better," a top World Health Organisation official said on Monday. . .

The review, starting in April, will be conducted by 29 experts, drawn by WHO regional offices from a pool of scientists and public health officials nominated by member states.

WHO Director-General Margaret Chan will report their preliminary findings to the WHO's annual World Health Assembly in May, with the final report due to be ready for the 2011 World Health Assembly, Fukuda said.
Surprisingly, The Lancet has elevated scurrilous comments to the level of reportage, in a March 20-26 article by Priya Shetty titled "Experts concerned about vaccination backlash."  A former president and communication officer of the European Society of Clinical Microbiology and Infectious Diseases, Giuseppe Cornaglia, claimed,
"Sending a clear message, however erroneous it might be, is how the anti-vaccination movement scored big with H1N1.  Their message was simply, 'Vaccines are the devil.'"
In contradistinction to Cornaglia's claim, I would submit that the transmission of factual information on the H1N1 epidemic (and available vaccines) resulted in fewer people choosing to be vaccinated, because they were able to make an appropriate risk/benefit decision for themselves and their children.  Deaths and injuries from swine flu can be counted in the developed world, but those from the vaccines cannot be--not with the level of knowledge and epidemiological tools currently available.

According to Tevi Troy, past deputy Secretary of DHHS,
The US decsion not to use adjuvants, which effectively expands the supply of the vaccines, stemmed in part from concerns about how the anti-vaccine groups would have reacted to adjuvants."
I would instead suggest that by accessing accurate information about adjuvants, and responding to the information, the public conveyed to its policymakers that it did not want these untested vaccine additives used for a disease associated with an extremely low mortality rate.  It is unfortunate the policymakers needed to be prodded, but very positive that the decision to omit novel adjuvants was made.  This probably helped prevent numerous future chronic autoimmune disorders.

Wednesday, March 24, 2010

Anthrax Questions/ Pittsburgh Tribune-Review

The U.S. Senate must help America get to the bottom of the post-9/11 anthrax attacks.
The FBI hasn't produced convincing answers. It had to pay damages to former government scientist Dr. Stephen Hatfill for wrongly labeling him a "person of interest."
It can't convict the government scientist it now blames, Dr. Bruce Ivins, because he took his own life amid FBI hounding.
And a National Academy of Sciences review of FBI scientific evidence, which the FBI itself ordered, isn't finished.
Yet the Obama Justice Department says it's a closed case.
As Cliff Kincaid of America's Survival Inc. notes, the FBI seems hellbent on exonerating al-Qaida. And left-leaning mainstream media have focused on domestic, preferably right-wing suspects -- despite evidence that al-Qaida strove to add anthrax to its arsenal.
So the Senate must follow the House's lead and require the intelligence inspector general to determine whether credible evidence exists of a link between a foreign entity and the anthrax attacks.
Mr. Kincaid chillingly points out that the FBI's handling of the case raises doubts about both its own practices and U.S. readiness for biological terror attacks. Without solid answers about the anthrax attacks, those doubts will only grow.

Sunday, March 21, 2010

Most Likely Source of Silicon in Anthrax Attack Spores Argues Against Production by Ivins

Writing at FireDogLake, Jim White discusses the role of silicon in the anthrax spores.  Apparently, the mechanism for 2 liter cultures of anthrax available to Bruce Ivins did not require an antifoaming agent, and he did not use one.  OTOH, large volume fermenters with compressed air (or a gaseous mixture) pumped into the culture medium do need the addition of an antifoaming agent.  Silicon-containing agents are popular, although agents are available without silicon.  Simethicone (a possibly effective medicinal treatment for "gas" pains that acts by reducing surface tension on gas bubbles) is one such agent.  Its inclusion in a fermentation might have led to a concentration of silicon compounds similar to what was found in the anthrax letters.  Much good technical information here.

Thursday, March 18, 2010



March 18, 2010
Contact: Zach Goldberg
202-225-5801 (office)


Also Urges Administration to Reconsider Position on Videorecording of Detainee Interrogations

(Washington, D.C.) – U.S. Rep. Rush Holt (NJ-12), Chair of the Select Intelligence Oversight Panel and a member of the House Permanent Select Committee on Intelligence, today responded to the Obama Administration’s concerns about two provisions he included in the 2010 Intelligence Authorization Bill that passed the House. One provision would require the Inspector General of the Intelligence Community to examine the possibility of a foreign connection to the 2001 anthrax attacks. Another provision would require the videorecording of all pertinent interactions between CIA officers and detainees arrested in Iraq, Afghanistan and elsewhere.
“I am not surprised at the FBI’s opposition to [a Congressional investigation], given the fact that they have stonewalled every House and Senate member who has sought information on this investigation over last decade,” Holt wrote. “What surprises me is that an Administration that has pledged to be transparent and accountable would seek to block any review of the investigation in this matter.”

A copy of Holt’s letter to Peter Orzag, Director of the Office of Management and Budget is below:

March 18, 2010
Peter Orzag
Office of Management and Budget
Eisenhower Executive Office Building
Washington, D.C. 20503

Dear. Mr. Orzag,
I am in receipt of your letter of March 15 to Chairman Reyes regarding the Administration’s concerns over two provisions I included in the Fiscal Year 2010 Intelligence Authorization Act (H.R. 2701). Let me begin by addressing the Federal Bureau of Investigation’s claims regarding my provision on the “Amerithrax” investigation.

As you may know, the 2001 anthrax attacks evidently originated from a postal box in my Congressional district, and they disrupted the lives of people throughout the region and the country. For months, Central New Jersey residents lived in fear of a future attack and the possibility of receiving cross-contaminated mail. Mail service was delayed and people wondered whether there was a murderer at large in their midst. Further, my own Congressional office in Washington, D.C. was shut down after it was found to be contaminated with anthrax. Therefore I have followed closely the case and the investigation.

In the wake of the attacks and at a number of points thereafter, a number of media reports—citing government officials, usually anonymously—suggested a possible link between the attacks and foreign entities. Most of these stories attempted to link Iraq to the attacks, but questions have also been raised about whether the strain of anthrax used in the attacks had been supplied to foreign laboratories. My provision in H.R. 2701 is designed to have the DNI IG address those issues, to determine whether, in fact, all available intelligence on this topic was supplied to investigators. The provision itself is unremarkable in its scope and does not, contrary to the Bureau’s assertion, constitute Congress directing the Inspector General of the intelligence community to “replicate” a criminal investigation. However, I am not surprised at the FBI’s opposition to it, given the fact that they have stonewalled every House and Senate member who has sought information on this investigation over last decade. What surprises me is that an Administration that has pledged to be transparent and accountable would seek to block any review of the investigation in this matter.

The Bureau has asserted repeatedly and with confidence that the “Amerithrax” investigation is the most thorough they have ever conducted—claims they made even as they were erroneously pursuing Dr. Steven Hatfill. Instructing the DNI IG to ensure that all intelligence information was in fact passed to the FBI would not “undermine public confidence” in the investigation. Many critical questions in this case remain unanswered, and there are many reason why there is not, nor ever has been, public confidence in the investigation or the FBI’s conclusions, precisely because it was botched at multiple points over more than eight years. Indeed, opposing an independent examination of any aspect of the investigation will only fuel the public’s belief that the FBI’s case could not hold up in court, and that in fact the real killer may still be at large. However, that is not the primary purpose of this provision in H.R. 2701. It is appropriate that the Intelligence Community contemplate whether it did consider this case and would consider a similar case properly to protect Americans from bioterrorist attacks. The people of central New Jersey, the Congress, and the Administration need to know that every lead—foreign and domestic—was supplied to the FBI and investigated thoroughly. My provision in H.R. 2701 would help ensure this goal is achieved, and I urge the Administration to support this provision.

Regarding my detainee videorecording requirement in H.R. 2701, I would remind you that comparable opposing arguments were offered last year for an extremely similar (and yet more stringent) video recording provision in the FY10 National Defense Authorization Act. I note that the President did not object to that provision, which is now law and which the Defense Department is implementing without difficulty. Indeed, that provision contains a waiver mechanism that the Secretary of Defense can exercise, provided he informs Congress of the reasons for suspending the videorecording sessions. I am happy to work with the Administration on crafting a similar waiver provision, provided that it does not compromise effective Congressional oversight of detainee interrogation policy.

Our police officers and prosecutors know well the value of recording custodial interrogations, which is one reason why then-State Senator Obama championed the use of custodial videorecording when he served in the Illinois state legislature. The intelligence community also clearly understands the value of it, as General Keith Alexander acknowledged to the House Permanent Select Committee on Intelligence in July 2004 regarding detainee interrogation videorecording conducted at Guantanamo, as revealed in documents made public through Freedom of Information Act litigation earlier this year.

Given the tremendous value that the recording of detainee interrogations provides to our intelligence community—and the protection it helps afford both the detainee and the interrogators—I trust the Administration will work with me and the committee to resolve this issue.

Thank you for your distinguished service to our nation.



Anthrax Investigation: What About the Silicon?/ Science

Science Magazine asks, "What about the Silicon?"  The 19 March 2010 issue contains an article by Yudhijit Bhattacharjee detailing all we don't know about the silicon in the anthrax spores sent to Senators Daschle and Leahy and to the NY Post, and the absence of spores containing silicon in Ivins' flask.  Excerpts follow:
That question has confounded investigators throughout the probe into the 2001 anthrax letter attacks, which the U.S. government formally concluded in February. Scientists inside and outside the government say there is clear evidence that the high levels of silicon found in the anthrax came not from anything added to "weaponize" the anthrax spores—as researchers had suggested early in the probe—but from the culture in which the spores were grown. That evidence may have settled the issue of whether the anthrax was weaponized, at least for scientists familiar with the case. But it raises a different question: Why did the mailed anthrax have such a high proportion of spores with a silicon signature in comparison to most other anthrax samples?
... The FBI's scientific case against Ivins rests on DNA tests showing that the mailed anthrax came from a flask under Ivins's control at the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, Maryland. Investigators also had the attack material chemically analyzed, first at the Armed Forces Institute of Pathology (AFIP) in Washington, D.C., within weeks of the attack. Examining the spores under a scanning electron microscope, AFIP scientists detected silicon and oxygen and concluded that the spores had been coated with silica to make them float easily, enhancing their power to kill.
But the Sandia study, presented last September to a National Academies panel reviewing the science behind the investigation, still leaves questions. Out of 124 spores from a letter mailed to Senator Patrick Leahy of Vermont, Michael found the silicon-and-oxygen signature in 97—78% of the sample. The signature was present in 66% of a sample from a letter to former Senator Tom Daschle and in 65% of spores from a letter sent to the New York Post.
Out of nearly 200 other anthrax samples from different labs, none came close to displaying such a prominent silicon signature. The highest, in a sample from Dugway Proving Ground in Utah, was 29%. The researchers couldn't find silicon in the coat of a single spore out of some 300 taken from RMR-1029, the flask in Ivins's lab identified as the source of the bacteria used in the attacks; they concluded that all the silicon had come from the culture.
The unusually high percentage of silicon-bearing spores in the attack material "is a bit of a strange thing," says Michael. "We have no way of knowing how they were really grown." An anthrax researcher who did not wish to be named calls it "awfully weird" and "a particularly inconvenient exception" because it leaves a gap in the case. However, neither scientist thinks the anomaly casts doubt on the broader investigation...

Wednesday, March 17, 2010

Letter from OMB to Chairs and Ranking Members of House/Senate Intelligence Committees

Here is the letter from OMB detailing the Obama Administration's objections to the Intelligence Authorization Act passed by the House on February 26, 2010. (Thanks to Steven Aftergood at the Project on Government Secrecy at the Federation of American Scientists for posting it, and for his insightful discussion.)

Tuesday, March 16, 2010

New way to be compensated for anthrax/smallpox vaccine injuries

from Vaccine News Daily:
... Besides the H1N1 vaccine, countermeasures currently covered by the CICP (Countermeasures Injury Compensation Program of the DHHS' Health Resources and Services Agency) program include vaccines and drugs for anthrax and smallpox, under HHS declarations made in 2008, according to Bowman.

Many members of the U.S. military receive anthrax and smallpox vaccinations, depending on where they are deployed. Bowman said the CICP covers claims from military members related to those immunizations, but so far the program hasn't received any claims from military personnel, he reported.

He said the program is planning to make a presentation to the Department of Defense's vaccine agency to inform officials about the program and to request that they provide vaccine recipients with information about it.

My interview about the anthrax case on Expert Witness/WBAI NYC

fyi, here is a link to the MP3 of a 55 minute interview with Michael Levine and Mark Marshall on the March 15 ExpertWitness radio program.

Admin Spin Docs Working Overtime

The ABC News blogger Jacob Tapper  ("Political Punch") provides more detail about what the administration is complaining about in the intelligence bill, and its anthrax issue.  Yet Tapper points out, 
In addition, the Intelligence Authorization bill would commission an agency inspector general to investigate the anthrax attacks, which the FBI has concluded were planned and committed by the late Dr. Bruce Ivins, acting alone.
As Salon's Glenn Greenwald has covered extensively, there are many members of Congress who question the FBI’s conclusion, including members of congress such as the former head of the State Department’s Nuclear and Scientific Division of the Office of Strategic Forces Rep. Rush Holt, D-NJ, from whose district the letters were sent; and Senate Judiciary Committee Chairman Sen. Pat Leahy, D-Vermont, whose office was targeted.
Moreover, having reported that scientists don’t think the “deadly bacterial spores mailed to victims in the US anthrax attacks” had  the same chemical “fingerprint” as those bacteria in the flask linked to Ivins, the science journal Nature recently wrote that the case was not closed. Editorial writers from the Washington Post and New York Times are similarly unconvinced.
 The spin docs in Tapper's piece have dredged up a litany of reasons why a veto is necessary.  Number 1, of course, is that the bill could cost American lives. How many times will they recycle this one?   Number 2 is that CIA can't video its interrogations because "The Obama administration says that 'conditions as they exist in real-time may not allow for the installation and assembly of video equipment, particularly if hostile forces are active at or near the site of the interrogation.'”  These days, when every cell phone includes a video camera, and professional videocams fit in a pocket, that excuse is a little old.  Number 3 is that it "would undermine the President's authority..."  Number 4 is that the administration resists oversight, in general, of intelligence agencies:  "Congress is also trying to bring the intelligence communities under the oversight of the  Government Accountability Office, which the administration opposes."  Another imperial presidency underway.

Obama threatens to veto greater intelligence oversight/ Glenn Greenwald (Salon)

Glenn Greenwald was a constitutional law and civil rights litigator in New York before becoming a writer on political affairs and constitutional law.  He is arguably the most perspicacious journalist offering political commentary today.  His comments on Obama's threatened veto of the intelligence authorization bill follow.
One of the principal weapons used by the Bush administration to engage in illegal surveillance activities -- from torture to warrantless eavesdropping -- was its refusal to brief the full Congressional Intelligence Committees about its activities.  Instead, at best, it would confine its briefings to the so-called "Gang of Eight" -- comprised of 8 top-ranking members of the House and Senate -- who were impeded by law and other constraints from taking any action even if they learned of blatantly criminal acts.

...efforts to ensure transparency and oversight have continuously run into one major roadblock:  Barack Obama's threat to veto the legislation.  Almost immediately after leading Democrats on the Intelligence Committee unveiled their legislation last year, the Obama White House issued a veto threat with extremely dubious (and Bush-replicating) rationales:  such oversight would jeopardize secrecy and intrude into "executive privilege."

...Read this October, 2009 article from The Hill -- headlined:  "Feingold sees similarities between Bush and Obama on intelligence sharing" -- in which Senate Intelligence Committee Member Russ Feingold explains "his suspicion that the Obama administration is continuing some of the stonewalling practices of the George W. Bush administration when it comes to providing full intelligence briefings to the relevant committees in Congress."  And indeed, all year long, there's been a series of disclosures about highly controversial intelligence programs that appear to be "off-the-books" and away from the oversight of the Intelligence Committee.  In late January, it was revealed that the President was maintaining a "hit list" of American citizens he had authorized to be assassinated far from any "battlefield," followed by yesterday's story describing the use of shadowy private contractors to collect intelligence in Pakistan and Afghanistan.

...The refusal of the Bush administration to brief the Intelligence Committees on its most controversial intelligence programs was once one of the most criticized aspects of the Bush/Cheney obsessions with secrecy, executive power abuses, and lawlessness.   The Obama administration is now replicating that conduct, repeatedly threatening to veto legislation to restore real oversight.

Marcy Wheeler notes what is probably the worst part of all of this, something I consider truly despicable:  the administration is also threatening to veto the bill because it contains funding for a new investigation of the 2001 anthrax attacks, on the ground that such an investigation -- in the administration's words -- "would undermine public confidence" in the FBI probe of the attacks "and unfairly cast doubt on its conclusions."
As I've documented at length, not only are there enormous, unresolved holes in the FBI's case, but many of the most establishment-defending mainstream sources -- from leading newspaper editorial pages to key politicians in both parties -- have expressed extreme doubts about the FBI's case and called for an independent investigation.  For the administration to actively block an independent review of one of the most consequential political crimes of this generation would probably be its worst act yet, and that's saying quite a bit.
 Amen, Glenn.

UPDATE:  And excerpts from the March 18 The Hill:
House Intelligence Committee Democrats are engaged in a fierce showdown with the White House over lawmakers’ demands for more transparency and oversight of the intelligence community.

President Barack Obama has twice threatened to veto the intelligence authorization bill, first in July of last year, when the committee approved it, and again this week....“Shame on them,” Eshoo, a senior member of the House intelligence committee said in an interview. “The president campaigned on the need for more transparency and accountability and better place [than the CIA], which doesn’t have any eyes and ears on its activity except for us here in Congress.”

Instead, she said, the Gang of Eight notification system should be abolished completely because the intelligence community is not really giving full and complete information to the exclusive group anyway, so any oversight role Congress is obligated to play is thwarted in the process.

Eshoo blasted Orszag's letter, saying it amounted to the administration wanting to maintain the “status quo” and forget providing any real oversight and accountability to the Intelligence panel.
“They don’t really consult with [Congress] at all,” she said. “This is really a drive-by, drop-off system. The American public deserves better.”

Monday, March 15, 2010

Reconstruction of a Mass Hysteria: The Swine Flu Panic of 2009/ Spiegel

From the March 12, 2010 Spiegel (my thanks to Jane Bryant's "OneClick" website for posting the story and to Digital Journal for covering it)

What the Spiegel does is to confirm that it was WHO's decision to move to Pandemic Phase 6 that caused preexisting contracts between nations and large vaccine manufacturers to become active, guaranteeing huge sales and profits to the companies. How did Pharma help move WHO to declare a Phase 6? The Spiegel's investigative report is an excellent start to unravelling this unholy alliance between international public health policymakers and industry. Enjoy the full article (excerpts below):
According to the regulations, phase 6 becomes effective when a new virus is spreading uncontrollably in several regions of the world. The regulations say nothing about the severity of the disease.

In fact, the vast majority of experts on epidemics automatically associate the term "pandemic" with truly aggressive viruses. On the WHO Web site, the answer to the question "What is a pandemic?" included mention of "an enormous number of deaths and cases of the disease" -- until May 4, 2009. That was when a CNN reporter pointed out the discrepancy between this description and the generally mild course of the swine flu. The language was promptly removed.

Apparently German infectious disease experts also misunderstood the official WHO definition of phase 6. An influenza epidemic, according to Germany's national pandemic plan -- updated in 2007 -- is "a long-lasting, international situation involving substantial loss…and causing such lasting damage as to jeopardize or destroy the livelihood of large numbers of people."

The situation on June 11, 2009 did not correspond with these descriptions. Critics were already asking derisively whether the WHO had any plans to declare the latest outbreak of the common cold a pandemic. "Sometimes some of us think that WHO stands for World Hysteria Organization," says Richard Schabas, the former chief medical officer for Canada's Ontario Province...

Everything hung on this decision. At stake was nothing less than a move to supply large segments of the world's population with flu vaccine. Phase 6 acted as a switch that would allow bells on the industry's cash registers to ring, risk-free. That's because many pandemic vaccine contracts had already been signed. Germany, for example, signed an agreement with the British firm GlaxoSmithKline (GSK) in 2007 to buy its pandemic vaccine -- as soon as phase 6 was declared. This agreement could explain why Professor Roy Anderson, one key scientific advisor to the British government, declared the swine flu a pandemic on May 1. What he neglected to say was that GSK was paying him an annual salary of more than €130,000 ($177,000).

In mid-June, 2009, the head of GSK's German division urged Health Minister Ulla Schmidt "to confirm the delivery stipulated under the contract as soon as possible." He also asked the health minister of the eastern state of Thuringia to "promptly provide us with binding confirmation of the contractually stipulated orders of the German states." Similar letters were sent to other German states...

Friday, March 12, 2010

Old WP editorial requesting Independent Commission or DOJ IG review of FBI anthrax case

From an Editorial in the December 1, 2008 Washington Post:
...The new attorney general also should ensure that an independent commission or the inspector general review the anthrax investigation. In the summer, the FBI identified Fort Detrick scientist Bruce E. Ivins as the lone suspect in the 2001 anthrax attacks that killed five and sickened many more. Mr. Ivins took his own life before he could be put on trial. An independent examination of the anthrax probe should review the methods used by the FBI in investigating Mr. Ivins and, before him, Steven J. Hatfill, who was the FBI's initial suspect before being exonerated this year. The review must also examine how Mr. Ivins maintained a security clearance despite apparently suffering from serious mental illness.

Tuesday, March 9, 2010

Anthrax Vaccine and EMS: Beware of Waytes Bearing Gifts

Tom Waytes, vice president of Emergent BioSolutions, the manufacturer of anthrax vaccine, spoke at a meeting of Emergency Services Personnel at which he suggested that expiring doses of vaccine should be given to Emergency Services personnel for *free* by DHHS:
"But with unused doses of already purchased anthrax vaccine sitting in the Strategic National Stockpile and reaching their expiry date (the vaccine has a four-year shelf life), Waytes thinks the time is right to take some of these expiring doses and make them available free to EMS personnel."
Why would the manufacturer want a $25/dose product given away??

Anthrax vaccine could be thought of as a modern Trojan Horse (that's where the phrase, 'Beware of Greeks Bearing Gifts' came from). Here's why:
  1. HHS is likely to keep expired doses in storage and use them, if needed, in the future. After all, that is what happened until 1998: expired lots were simply given a new expiration date, after being tested for potency using a test that was known to be worthless. (Bruce Ivins got an award around 2007 for helping develop a better test.) So if expiring vaccine gets used up, HHS is more likely to replace it than if it expires and remains in storage, increasing Emergent BioSolutions' profits.
  2. A gift of anthrax vaccine will be the gift that keeps on giving--to Emergent Biosolutions. You see, even after 5 initial shots you still need a yearly booster. So a fireman, for example, would need 23 separate shots during a 20 year career to stay up-to-date on the vaccine.
  3. Anthrax vaccine has made thousands of people sick. Even the vaccine label lists Gulf War Syndrome (using the CDC's definition) as a reported side effect. But Emergent BioSolutions could care less, since they bear no responsibility. On October 1, 2008, Republication DHHS Secretary Michael Leavitt issued an "Emergency" declaration for anthrax vaccine under the Public Readiness and Emergency Responsiveness Act (PREPA), removing essentially all liability from the manufacturer in case of deaths or injuries due to the vaccine. If you suffer a permanent disability or death, the best you can do is hope to collect a little money from the federal government (and the maximum is about $300,000).
  4. Three weeks after Leavitt's declaration, the CDC had its Advisory Committee on Immunization Practices recommend expand anthrax vaccine use to "at risk" civilian first responders. (But who is really at risk? No one knows.) I don't believe the timing was an accident. Emergent wanted to increase sales while continuing to avoid liability for a vaccine that maims and occasionally kills. Soldiers have been barred from suing Emergent in the past, but civilians didn't have the same restriction. So the Bush DHHS obliged with an emergency declaration, followed by a recommendation to expand the vaccine's indications. The Obama administration has failed to remove or amend the PREPA declaration for anthrax, and has failed to remove or amend later declarations for smallpox and multiple influenza pandemic vaccines.

Sunday, March 7, 2010

My summary of unresolved issues in the anthrax letters case

In terms of the strength of the FBI’s case against Ivins, I would break down an analysis in the following way:

1. To prove that a person committed a crime, they must be shown to have all three of the following: means, motive and opportunity. Has the FBI proven that Ivins had all three?

a) Means: Retired colleagues have said he did not have the equipment to make Daschle-quality anthrax in the amounts required using equipment available to him at Fort Detrick. Anonymous colleagues at Fort Detrick claim he could. FBI has failed to clarify this major issue. FBI has not been able to “reverse engineer” the anthrax and therefore does not know what equipment was needed to produce it. FBI has made a series of changing claims over time about silicon found in the spore preparation. UPDATE: Ezzell and Mohr (not anonymous colleagues) told Scott Shane/NYT that Ivins had the equipment to produce the anthrax powder. LATER UPDATE: After Ezzell was interviewed and allegedly said Ivins had the equipment to make the spores in the anthrax letters, another coworker queried Ezzell on this. Ezzell claimed that his statement had not been conveyed accurately, and that he had referred only to the first set of letter anthrax, which was clumped, not free-flowing and contained extensive debris. This "rough" preparation of anthrax could have been made in the available speed vac.

So there do not appear to be any coworkers who allege that Ivins could have produced the Daschle/Leahy letter anthrax in his Fort Detrick laboratory.

b) FBI has not identified the Bacillus strain contaminant (found in the first letters) in the Fort Detrick lab, suggesting the spore material was made elsewhere.

c) Motive: The FBI has alleged a variety of motives at different times, but none of them seem to make any sense. The latest report has errors of fact in its discussion of motive.

d) Opportunity: Could Ivins have made it to the Trenton/Princeton area to mail letters and returned to Frederick in time to meet his other obligations? The FBI’s first reported (2008) scenario of how this may have occurred was incorrect. I have not read a convincing scenario since.

2. What is the evidence amassed by the FBI for and against Ivins? The documents released in February 2010 were selected to prove his guilt using circumstantial evidence and character assassination. What about other evidence?

3. What evidence did the FBI have against earlier suspects, including Steven Hatfill and Perry Mikesell? Why did FBI wait until after Ivins’ death to exonerate Hatfill, months after he received a several million dollar settlement from the government?

4. Ivins’ death scenario begs many questions. Why wasn’t he given a Tylenol antidote to prevent liver failure? Ivins was allegedly found unconscious on the bathroom floor with an orange liquid next to him. A Tylenol overdose requires several days before you die, and does not cause coma for days. If the benadryl in Tylenol PM led to unconsciousness (according to a later account by Scott Shane in the NY Times) there was still time to treat him successfully for Tylenol toxicity. Ivins was under 24/7 surveillance by FBI, from the house next door. FBI should have identified an overdose before several days had passed, and the window of opportunity for treatment was lost. FBI could have furnished Ivins’ medical providers with information that might have saved his life. The medical records of Ivins’ hospitalization have not been released.

5. The FBI’s account of Ivins using “classic” countermeasures to outsmart a lie detector test is nonsense, according to a former FBI agent (Drew Richardson, PhD) with broad experience in this area, who has provided Congressional testimony on polygraph testing. Initially it was reported that Ivins had passed two polygraph tests. What did the second test show?

6. How were other potential perpetrators ruled out? (Dr. Drew Richardson says that polygraph tests would not be sufficient to rule other suspects out.) How was a crime involving more than one actor ruled out?

7. Why did the FBI "try" Ivins in the media during early August 2008, using a series of leaks, for which FBI later apologized?

8. Why did FBI close the case with no additional hard evidence, apart from a new theory about a DNA code within the anthrax letters, months before the National Academy of Science report on FBI’s forensic science, commissioned by FBI, was released?

There are a number of additional issues, but these should suffice to indicate the FBI’s case is entirely unsatisfactory.

Meryl Nass, MD
March 7, 2010

Saturday, March 6, 2010

Jean Duley emerges from undisclosed location after 18 months to bolster FBI's case against Ivins

Jean Duley gave Anderson Cooper the scoop (watch the video!) on Bruce Ivins.

Not to put too fine a point on it, but a few facts are in order. Ms Duley was well known to the Maryland police. Her past charges included possessing narcotics paraphernalia, battery, and many DUIs, including a guilty plea 3 months before Ivins' death. She was under house arrest for 3 months when she began colluding with the FBI.

Whether the FBI used the carrot or the stick to elicit a litany of Ivins' alleged confessed crimes from the mouth of Duley, and to variously put her in front of the TV cameras or hide her from the press, the fact remains she has been the only person to publicly allege that Ivins previously attempted murder and planned other crimes. None of Ivins' psychiatrists or past therapists, nor any of Duley's supervising mental health professionals, have supported any of Duley's allegations. Had Ivins confessed to carrying out or planning such crimes, the law would have required Duley's supervising physician to call in the police much earlier. In fact, Ivins had no police record whatsoever in Maryland.

Remember, Duley had only just received a Bachelors Degree when she was put in the position of counselling Ivins for substance abuse. She has neither the training nor experience to comment to the media on Ivins' psychological pathologies, let alone treat them. She was not qualified to do anything more than substance abuse work, and as someone who had fallen off the wagon, was not even qualified for that.

However, her long prior experience as a member of a biker gang and multisubstance abuser since age 10 may have given her information about control and bondage, etc.

Ms. Duley is as pathetic a figure as Bruce Ivins. Her short career is over. She is a marionette in a theatrical piece, who will fade into obscurity now that she's helped "clinch" the FBI's case.

NAS Report: Weaknesses Found in Safety Assessment of Planned Fort Detrick Biodefense Lab/ GSN

Excerpts from Global Security Newswire:
The U.S. Army should fine-tune its procedures for determining safety risks in its projects following slip-ups in plans for the new site of the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., a National Academy of Sciences committee said in a report issued Thursday (see GSN, Sept. 23, 2009)...

The Army provided insufficient evidence to back its conclusion that a release of the Ebola and Q-fever agents from the new facility would pose no threat to residences and commercial sites in Fredrick, a community numbering roughly 59,000 people, according to an NAS statement.

The service did not adequately assess personal risk of contamination or disease contraction, nor did it address exposure risks for workers within the new laboratory, according to the report...

In addition, the Army did not explore possible security threats posed by laboratory personnel, the committee stated...

Biggest swine flu regret for U.S.: vaccine chaos/ Reuters

WASHINGTON - First, people were clamoring for H1N1 vaccines, but there were not enough to go around. By the time vaccines were available in any quantity, most of the public had lost interest.

And no one knew just how unpredictable the production of vaccines would turn out to be, top U.S. public health leaders agreed on Friday.

Getting the U.S. public to roll up their sleeves and get vaccinated was definitely one of the biggest challenges to managing the pandemic of H1N1 swine flu, speaker after speaker agreed at a conference on influenza regrets.

"The truth is for this pandemic we had about the longest warning we might ever have for a potential biothreat," said Dr. Nicole Lurie, who heads preparedness at the Health and Human Services Department.

"And yet we all lament how long it took for vaccine to be made," she told the conference, sponsored by the Center for Biosecurity at the University of Pittsburgh Medical School. (This is an excellent argument for why the US Government should not be putting its pandemic response money into vaccines: they are too uncertain and take too long to be manufactured and tested. As I testified to the Committee on Government Reform in 2001, a smarter way to respond is to identify the virulence factors from known pathogenic microorganisms and develop drugs and monoclonals in response to them--producing a generic supply of remedies ahead of time--Nass)

... First, vaccine makers had trouble growing the virus. Then there were problems getting vaccines into vials and shipped. And, experts told the meeting, other problems popped up.


The CDC says that by February 13, as the pandemic waned in the United States (the truth is, according to CDC, the pandemic peaked in late October and waned thereafter; on February 13 the rate of positive flu specimens was less than 2% the rate at the October peak--Nass), only 97 million H1N1 vaccine doses had been given to 86 million people in the United States, or 78 percent of doses shipped... ("In mid February, Health and Human Services Secretary Kathleen Sebelius estimated that 70 million Americans had received the vaccine so far... the CDC added that the precise number of doses that have been administered is not known." Yet CDC has a weekly tally of exactly how many doses were given, but they won't admit it--Nass)

Further complicating things -- the United States uses five suppliers, each of whom made vaccine in a slightly different way. MedImmune's nasal spray was great for children but inappropriate for high-risk adults and some of the shots were not indicated for young children.

The CDC and HHS had to patch together an ad hoc network of private manufacturers, a private distributor and numerous retail clinics, hospitals, doctor's offices, employers, state and city health departments.

And Americans were on their own to decide if and when to get vaccinated.

"Our colleagues in the U.K. said no problem -- we just tapped into the electronic health records," Frieden said. They were able to identify patients with high-risk conditions and invite them to come in and be vaccinated by appointment.

And then there were the rumors the vaccine was not safe. "We can't ever be in a situation again where we have a countermeasure that half the public won't accept," Lurie said. (This article sounds like a segue into mandatory pandemic vaccines--stay tuned--Nass)

UPDATE: Dr. Lurie was the person responsible for swine flu vaccine procurement, though she lacked experience in this area. Her last statement can be read two opposite ways: she may be saying we have to do a better job getting a proven safe and effective vaccine to the public more quickly... but since she was the person who got it to the public late with little testing, it is more likely she is saying that next time, she'd prefer the public be required to "take it and like it."

Friday, March 5, 2010

Nadler Renews Call for Independent Investigation of Anthrax Attacks

Thursday, 04 March 2010 WASHINGTON, D.C. – Congressman Jerrold Nadler (D-NY), Chair of the House Judiciary Subcommittee on the Constitution, Civil Rights and Civil Liberties, reiterated his call for an independent investigation into the 2001 anthrax attacks which killed five people and sickened 17. He issued the following statement:

“Despite the FBI’s assertion that the case of the anthrax attacks is closed, there are still many troubling questions. For example, in a 2008 Judiciary Committee hearing, I asked FBI Director Robert Mueller whether Bruce Ivins was capable of producing the weaponized anthrax that was used in the attacks. To this day, it is still far from clear that Mr. Ivins had either the know-how or access to the equipment needed to produce the material. Because the FBI has not sufficiently answered such questions, I join Congressman Holt in urging an independent investigation of the case.”


March 3 Letter from Congressman Holt asking for a Congressional Investigation into the government's handling of the anthrax letters investigation. Rep. Roscoe Bartlett supports this also. A brief excerpt follows, addressed (respectively) to the chairs of the House Homeland Security, Judiciary, Select Intelligence and Oversight and Government Reform Committees:
Dear Chairmen Thompson, Conyers, Reyes, and Towns,

I am writing to ask that your committees, either individually or jointly, conduct a probing investigation of our government’s handling of what has been known as the “Amerithrax” investigation...

Given its track record in this investigation, I believe it is essential that the Congress not simply accept the FBI’s assertions about Dr. Ivins' alleged guilt. Accordingly, I ask that your committees investigate our government’s handling of the attacks, the subsequent investigation, and any lessons learned and changes in policies and procedures implemented in the wake of the attacks.