Disposing of excess swine flu vaccine: government pays again

This article from the Bucks County Courier Times doesn't address how the 25 mcg. mercury-containing doses (in multidose vials) will be handled, since release into landfills and rivers is not safe or acceptable. Most swine flu vaccine used in the US was packaged in multidose vials, including a mercury preservative, with small stocks of single dose vials reserved for young children and pregnant women.

Too bad the vaccine product wasn't made with a longer expiration date, since this vaccine will be included in the 2010 fall-winter flu vaccine shot.  So our taxes pay to destroy excess vaccine capacity and then pay to buy more identical vaccine antigen for the coming winter's vaccine.  What a brilliant business model.

Excerpts:

Stuck with thousands of unused swine flu shots, local health care providers find themselves paying to discard flu vaccine for the first time in recent memory...

Meanwhile, a Centers for Disease Control and Prevention spokesman said the agency is preparing a swine flu vaccine disposal plan but won't offer suggestions in the meantime...

UPDATE April 13:  (Reuters) "It is too soon to determine whether tens of thousands of doses of H1N1 swine flu vaccine may have to be thrown out if they are not used before their expiration date, a U.S. health official said on Thursday... Dr. Anne Schuchat, head of the CDC's National Center for Immunization and Respiratory Diseases, said it was difficult to say how many H1N1 vaccine doses may be discarded."  Yet Pennsylvania's state health department reports it has already disposed of 27,000 doses.  And those doctors and clinics left holding the bag (I mean vials) will have to pay themselves to dispose of what is left. UPDATE 2 April 24:  Allegheny County, Pennsylvania has 100,000 doses to destroy, plus an unknown amount in doctors' offices and clinics.
 
Hello?  The US ordered 251 million doses of swine flu vaccine, according to the LA Times, or 229 million doses, according to Reuters.  It used 1/3 of this stockpile.  Yet instead of admitting there are about 150 million excess doses, most or all of which will expire before the next flu season, A "US health offical" loses 4 decimal places (4 orders of magnitude) and suggests that only tens of thousands of doses may have to be discarded.

Furthermore, the amount spent worldwide to respond to the swine flu pandemic has suddenly shrunk, according to the American delegation to a WHO meeting on swine flu and the role of WHO.  It was only 4 billion dollars, claim the Americans, citing a World Bank estimate.

Yet vaccine cost about $10/dose in the US, so that was about $2.5 billion alone.  The cost to administer the vaccine (wages for those holding clinics, costs of advertising the clinics, syringes, gloves, etc.) is approximately $10-20/dose.   Add to that the costs of Tamiflu and Relenza.  So the cost of the swine flu preparedness program in the United States alone exceeded the alleged cost to the world of swine flu preparation.

UPDATE 3 (April 28): The UK won't admit what it spent on Swine Flu, but Glaxo earned 700 million pounds (1.07 billion dollars) in swine flu revenue during the first quarter of 2010.

Do our government health agencies think the public has no memory and cannot do arithmetic? Where are the names of these anonymous spokespeople?  Is anyone accountable for these spending decisions and shifting of health priorities?

Experts Debate Extent of FDA Reform in Wake of Whistleblower Testimony/ Medscape

From the April 5 Medscape:

... The testimony repeated charges that Dr. Nicholas made in a letter last December to HHS Secretary Kathleen Sebelius and FDA Commissioner Hamburg. He disclosed that he had sought an FDA warning label on the CT scanner in question that would highlight the risk for radiation-induced cancer, noting that between 1.5% and 2% of all cancers "are directly attributable to radiation exposure from CT scanning."

"You could imagine the appalling consequence," Dr. Nicholas wrote Ms. Sebelius and Dr. Hamburg, "of clearing a device that may not be as effective as [optical] colonoscopy, that may be misused to actually prevent patients from being studied with colonoscopy, and that may also cause radiation-induced cancer."
"I was continually harassed and pressured to change my review by managers, but because of my commitment to the public, I could not in good conscience do so, absent a valid scientific reason. I was intimidated and ultimately suffered the most severe form of retaliation against any employee engaged in whistleblowing activity — termination..."

Dr. Nicholas's allegations were riveting, but they are not new. In a series of group letters to Congress and the White House going back to 2008, FDA physicians and scientists depicted the FDA as a broken, corrupt institution more beholden to medical device manufacturers and the politicians that lobbied on their behalf than to the public it was supposed to protect.

An April 2 letter to President Barack Obama stated that despite new leadership at the very top, the agency still abounded with veteran managers who have "violated laws, rules and regulations; who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out." The letter recommended disciplinary action against such employees, adding that some cases might need to go to the US Attorney General's office...

Steven Findlay, a senior health policy analyst at Consumers Union (the publisher of Consumer Reports), noted that the agency's tilt toward drug and device makers began before George W. Bush became president. "The culture at the FDA has been problematic for many years," he said. "But it became more acute during the Bush administration," he noted...

More Mandatory Vaccinations Planned for Healthcare Workers/ Inf Disease News

From Infectious Disease News:

ATLANTA, March 18, 2010 — Mandatory vaccination policies increased the number of health care workers who received the influenza vaccine during the 2009-2010 influenza season, according to results from two studies presented here at the Fifth Decennial International Conference on Healthcare-Associated Infections...

Researchers in the first study analyzed the outcomes of a mandatory vaccination/declination policy instituted by the Hospital Corporation of America in 163 hospitals, 112 outpatient centers and 368 physician practices in 20 states. The policy required all health care personnel to receive the influenza vaccine or be reassigned to nonpatient contact roles or use surgical masks.

Ninety-six percent of the hospital employees received their seasonal influenza vaccine by Nov. 1, which was a 65% increase in vaccination rates vs. the mean 58% during the previous season.

“We expect to move forward using this vaccination campaign strategy for future influenza seasons, and we expect other health care institutions to follow suit,” said Jonathan Perlin, MD, PhD, chief medical officer of Hospital Corporation of America. “Our approach enhanced patient safety and our employees delivered with an overwhelming response.

A second study evaluated the disparities in employee vaccination rates over a five-year period at the Children’s Mercy Hospitals and Clinics in Kansas City, Mo. This hospital also implemented a mandatory vaccination/declination policy in 2008, and vaccination rates rose from 63% to 85%. The addition of certain consequences during the 2009-2010 season, including forced leave of absence for noncompliance, further increased rates to 98.8%. 

“Our dramatic increase in vaccination participation over the last few years has been astounding,” [threaten peoples' jobs during a recession and they comply--why is that astounding?--Nass] said Robyn Livingston, MD, director of infection control and prevention at Children’s Mercy Hospitals and Clinics. “Even though the program has exceeded our expectations, we recognize there is still room for improvement. We are considering a fully mandatory influenza vaccination policy to begin next fall.”

Gardasil trial stopped in India after 4 girls aged 10-14 die/ dnaIndia

According to DNAIndia,

... The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche...

More from The Hindu:

Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it by the Bill and Melinda Gates Foundation for assessing the feasibility of introducing HPV vaccine in India. Merck and GSK were to provide the vaccine and ICMR helped in protocol preparation.

Initially, the NGO conducted a survey of the social acceptability of the project with the help of a questionnaire among the socially disadvantaged groups, as cervical cancer occurred more among the women from the disadvantaged sections with less health facilities and low-capacity for buying expensive drugs. By the time the trial ended, the Drugs-Controller of India gave approval for marketing the two vaccines.

Pointing out that the trial started after approval from the State Advisory Committees and the ethical committees of the Andhra Pradesh and Gujarat governments and the National Technical Advisory Group as per the agreement with the NGOs, Dr. Katoch said: “Everything was going fine until we received complaints of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were given this vaccine.”

Bruce Ivins: Important new info reported by former colleague Henry Heine

Excerpts from interview with Dr. Heine interview on wfmd and Lew Weinstein's "Case Closed" blog:

"It was clear that they were focused on a small group of us at USAMRIID, one of which was Bruce.   Of the 4 or 5 of us they were focused on, one of them was Bruce.

Dr. Heine says all the USAMRIID scientists were interviewed in mid-October 2001 on where they were on the dates of mailing. (Comment: What did Dr. Ivins say when asked within 2 weeks of the mailing? Why wasn’t his response at the time provided?)

Dr. Heine says that the drying equipment that would be needed was not available — and not protected — in Dr. Ivins’ workspace.  He says Dr. Ivins did not have the knowledge or expertise to grow up large amounts of bacteria — it would have been impossible for Bruce to do.  He says lyophilizer was in non-containment area and could not have been used.

On the government having it all rely on Flask 1029, he analogizes it to the situation of the guy at the Walmart and blaming him for a shooting in town because he had control of the bullets at one point under the counter. He says that’s all they have — and implies that is ridiculous."

Canada: We Were Right. Prior (non-swine) flu shots increased risk of getting swine flu infection/ US News

The traditional seasonal flu vaccine may have increased the risk of infection with pandemic H1N1 swine flu, according to the results of four new studies by Canadian researchers, published in PLOS Medicine.
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly.  Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent.  (Then the license is withdrawn.) For details, see my prior post on this topic.  According to a detailed article in CIDRAP:

If that finding is not the result of chance or bias that occurred despite careful study design, the researchers say, then several hypotheses might explain the increased risk. Immunization might block the cross-protective immunity created by an earlier infection. "Original antigenic sin," or immunologic memory dating back to someone's first flu infection, might create antibody responses that are cross-reactive to other flu strains, but not strong enough to be cross-protective, and thus do not neutralize the virus. Or a related phenomenon called "antibody-dependent enhancement" might lead antibodies to inadvertently enhance virus uptake and production.

Immunity is not a simple thing.  Vaccine theory is in its infancy, and vaccine development is based on trial and error. 

Here then may be a rather serious unintended consequence of flu vaccination:

The researchers found that (getting an earlier year) seasonal flu vaccination was associated with a 68 percent increased risk of getting swine flu (infection).

UK used only 5% of the H1N1 vaccine originally ordered/ BBC

The UK government originally contracted for 120 million doses of swine flu vaccine; it was able to cancel some contracts (by agreeing to buy bird flu vaccine for an epidemic that does not exist, and buying extra flu drugs from GSK), but still purchased 44 million doses.

Only 6 million doses were actually used.  The total cost of the swine flu vaccine procurement was not stated, but probably approaches a billion dollars.  (Neither the UK government nor the manufacturers will divulge the actual price.)  According to Business Week and the Independent:

GSK is in talks with a number of other administrations over plans to par back vaccine orders. A host of northern hemisphere countries are known to want to slash orders after the initial spike in incidents of swine flu cases quickly tailed off. Among them, France, Belgium and Spain are thought to be in talks with GSK.

The company said that it would not be altering its earnings estimates for 2010, saying that it expects to see swine flu vaccine sales of about £880m this year, a similar amount to 2009.

Facts about H1N1 epidemic and vaccine in Australia/ Australian Prescriber

Professor Peter Collignan provides us with facts (finally we get to see some unvarnished information) on how bad the H1N1 virus was for healthy people, as well as learning of much higher adverse event rates for the vaccine than have been previously reported.  However, the CSL vaccines used in Australia were almost certainly different than the vaccines used in the US.  Only one in a million healthy people under age 40 (omitting pregnant women) died.  CDC never broadcast this figure.

In the 2009 Australian winter, swine flu's associated mortality rate was 0.9 per 100 000 people. In those under 40 years with no risk factors, the mortality rate was less than one per million.  While there were some differences (for example pregnant women), the overall effects of this virus as judged by absenteeism, hospitalisations and deaths were similar to those of previous seasonal influenza strains...


In an Australian H1N1 vaccine trial of adults (aged 18–65 years), 27% had protective antibody concentrations and 62% had detectable pre-existing antibodies...

In Australia, we do not have good postmarketing surveillance mechanisms in place and mainly rely on voluntary reporting. This is unlikely to accurately measure the percentage of people who get adverse effects or to identify rare adverse effects in a timely fashion...

The reason these issues are important is that we do not have robust data on which to make proper decisions on the cost-effectiveness of any mass vaccine programs. In young people without risk factors, the rates of death and complications last winter from swine flu were very low and are similar to the risk of serious vaccine-associated adverse effects such as Guillain-Barré syndrome and anaphylaxis. Around 50% of people who received the H1N1 vaccine in the Australian trial had mild to moderate systemic adverse effects and 1.7% had (solicited) systemic adverse effects recorded as severe.  In children, 20% had moderate to severe systemic adverse effects after receiving a single 15 microgram dose of vaccine.  It is very important that we make sure we do more good than harm with any vaccine.

Tories will reopen probe into Dr Kelly's 'suicide' (if they win election)/ Mail Online

From the Daily Mail, excerpts follow:

The investigation into the death of Dr David Kelly would be re-opened under a Tory government, according to a senior Conservative.  Shadow Justice Secretary Dominic Grieve said the public has 'not been reassured' that the Whitehall scientist took his own life.

Mr Grieve said that, if the Tories take power, he would 'review' the evidence that Dr Kelly killed himself - a conclusion which has been repeatedly challenged by experts.  An inquiry led by Lord Hutton concluded that the scientist committed suicide in July 2003... [However]
The campaigning doctors say the artery Dr Kelly severed is too small and difficult to access and cutting it could not have caused death...

Mr Grieve's letter, to Dr Michael Powers QC, an expert on coroners' law, follows revelations that Lord Hutton secretly ruled that evidence relating to the case, including Dr Kelly's post-mortem report, should not be released for 70 years.  Lord Hutton later said he would be happy for the doctors to see the records, including photographs of Dr Kelly's body, but still the information is being withheld.  When asked this weekend for his view on the Ministry of Justice's delay in releasing the documents, Lord Hutton refused to comment.

Liberal Democrat MP Norman Baker has claimed Dr Kelly did not commit suicide and might have been the victim of a murder and subsequent cover-up.

Maine Voices: U.S. intelligence reform top priority/ Portland Press Herald

Op-Ed written by Meryl Nass, published April 6:

A surprising tug of war has erupted between the Obama administration and Congress over transparency and oversight of the intelligence agencies.  In September 2009, the Senate passed the 2010 Intelligence Authorization Act, and on Feb. 26 the House passed a similar bill. They were about to be melded. But on March 15, Peter Orszag, director of the Office of Management and Budget, threatened a presidential veto if provisions of “serious concern to the intelligence community” were included.

Congress had many concerns about U.S. intelligence. The intelligence services provided no warning before Sept. 11, 2001. The intelligence that supported going to war in Iraq was deeply flawed; failures of intelligence collection, sharing, analysis and supervision were evident.

WHAT WERE THE CONCERNS?

What were the Obama administration’s concerns? The first involved notifying Congress of covert activities and other intelligence matters.

Currently, certain matters are only briefed to the “Gang of Eight” – the Senate majority and minority leaders, the House speaker and minority leader, and the chairmen and ranking members of the House and Senate intelligence committees. Although they are “briefed,” they may not take any notes, may not be accompanied by staff, and may not discuss the briefing with anyone. The process neither seeks congressional approval nor allows for objections.

Understandably, Congress wanted to expand such notifications and include all members of the intelligence committees. Congress also sought information on the “legal authority under which an intelligence activity is being or was conducted.” The administration resisted both provisions.

Orszag further objected to a provision in the new bill that would give the Government Accountability Office, the investigative arm of Congress, broader authority to conduct investigations of the intelligence community. Ironically, Adm. Dennis Blair, the current director of national intelligence (and a native of Kittery) had agreed with this during his confirmation hearing last year.

Other objections included the requirements to videotape interrogations and obtain Senate confirmation for additional leadership positions within the intelligence community, and conduct further investigation into the anthrax letters case.

The FBI closed the anthrax case last month despite dozens of unanswered questions. The administration claimed that further investigation “would undermine public confidence … and unfairly cast doubt on its conclusions.” But why shouldn’t Congress review an unsatisfactory conclusion to a crime that had profound repercussions for our country?

Congress has the duty to pay for and oversee federal expenditures, and make sure federal programs accord with our laws. If the tools available are inadequate to the task, more tools must be forthcoming.
Recent congressional precedent, alluded to by Orszag, took a “hands-off” approach to intelligence. The current administration wants the hands-off approach to continue. But is it wise?

Recent precedent led to violations of our Bill of Rights: Warrantless wiretapping by the National Security Agency is prohibited by the Fourth Amendment’s protection from unreasonable search and seizure.

“Extraordinary rendition” is prohibited by the Fifth Amendment’s requirement for due process of law.
Incarceration for years, without benefit of legal counsel, is prohibited by the Sixth Amendment’s rights of the accused, including the right to a speedy trial.

The Eighth Amendment prohibits cruel and unusual punishment (torture), as do our treaties.

These violations arguably make our nation less safe. Thus Congress has a clear mission to oversee and correct the conduct of the intelligence agencies. Do others agree?

SEEKING BETTER OVERSIGHT

The 9/11 Commission Report asked for improved congressional oversight of intelligence, noting, “Of all our recommendations, strengthening congressional oversight may be among the most difficult and important.”

The Report of the President’s Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction warned, “The intelligence community is a closed world, and many insiders admitted to us that it has an almost perfect record of resisting external recommendations.”

Maine’s Sen. Olympia Snowe introduced important new oversight provisions in the 2010 Intelligence Authorization Act.

It is critical for her and the rest of Congress to have the public’s support of their efforts to improve performance and accountability in the intelligence community.

Health Care Costs (Large Savings Await for a Gov't that Wants to Save)/NYT

Recall that FDA's Device Center was recently shown to make political decisions re medical device approvals, and to grandfather in devices on the basis of earlier approvals of very different devices.  GAO wrote several damning reports including this one from June 2009: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments.  GAO pointed out in January 2009 that only cursory reviews were taking place for most devices.  Thus the Center's Director was let go.

Yesterday's NYT reports on devices that fail, and how the health care system has to eat the very expensive results of such failures.  But in the US, medical devices come with no warranty:

When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers.

The article points out that the new healthcare bill should have addressed this issue, but did not.

Technologies Underlying Weapons of Mass Destruction/Office of Technology Assessment

In 1993 the US Government knew that silicon was used to enhance dispersal of powdered microbial agents and toxins.  OTA produced some very useful research, but the agency no longer exists.

U.S. Congress, Office of Technology Assessment, Technologies Underlying Weapons of Mass Destruction, OTA-BP-ISC-115 (Washington, DC: U.S. Government Printing Office, December 1993).

CHEMICAL ADDITIVES
The stability of a microbial aerosol can be
increased by adding a variety of compounds to the
spray material.58 Moreover, antiagglomerants such
as colloidal silica help prevent the clumping of
freeze-dried microbial agents and toxins that have
been milled into a fine powder.

The Anthrax Attacks and the System That Perpetrated Them — Barry Kissin _on Guns & Butter

This show was broadcast March 29, 2010.

It is now archived here  (But note that the linked website has an annoying "radio" in the upper right corner that turns itself on several times during the radio interview, and must be turned off immediately so the interview can be heard.)

Health official charged in flu vaccine buy/ UPI

SOFIA, Bulgaria, April 2 (UPI) -- Bulgarian Health Minister Bozhidar Nanev resigned after being charged with corruption in the purchase of unnecessary H1N1 flu vaccine doses.
Nanev, 57, was charged with overspending on 200,000 doses of vaccine from the highest bidder weeks after a flu epidemic had ended, The Sofia Echo reported.
Prosecutors allege Nanev signed a deal with Swiss drug maker Roche in December that cost more than $1.6 million more than a lower bid received 20 days earlier from Britain's National Health Service.
Nanev denied the charge and was free on bail, the EU Observer said.
The vaccine is in storage and has a 2014 expiration date, the Echo said.

Anthrax Investigation: Silicon Mystery Endures in Solved Anthrax Case/ Science

Science 19 March 2010:
Vol. 327. no. 5972, p. 1435
News of the Week
Yudhijit Bhattacharjee

What about the silicon?

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 answer, according to academic scientists who helped with the case, probably would not change the FBI's conclusion that the attacks were the sole handiwork of now-deceased U.S. Army researcher Bruce Ivins. But it could help illuminate exactly how the attack material was prepared. Resolving the mystery might also pave the way for new techniques using trace elements in a bioterrorism agent to link it to its source.

"There's tremendous interest in using metal signatures as a forensic tool," says Adam Driks, an anthrax researcher at Loyola University Chicago in Illinois. But the science to do that is lacking: "We know very, very little about the diversity of elemental composition within spores when they are produced in different ways."


Closer look. Michael (above) saw silicon well inside individual spores, visible as the green lining in the top right image.

CREDITS: SANDIA NATIONAL LABORATORIES

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.

A more detailed analysis by Joseph Michael and Paul Kotula of Sandia National Laboratories in Albuquerque, New Mexico, contradicted that conclusion. Studying individual spores with a transmission electron microscope, they found that the silicon was located within the spore coat, well inside the cell's exosporium (outermost covering). By contrast, when they looked at surrogate spores weaponized with silica, the silicon was clearly outside the exosporium.

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.

The key to the mystery likely lies in the culture medium the perpetrator used to grow the anthrax spores, says Michael. In a recent study, Japanese researchers grew colonies of Bacillus cereus—a close relative of the anthrax bacterium, B. anthracis—in culture media with and without added silicate. Spores grown in the silicate-containing culture showed silicon within the spore coat. In the absence of silicate, there was no silicon, the group reported in January in the Journal of Bacteriology.

One of the study's authors, microbiologist Akio Kuroda of Hiroshima University in Japan, says the precise amount of silicon in individual spores from the anthrax letters could offer clues about the medium. "If the anthrax spores contained a high amount, the suspect must have used a medium that was supplemented with silicon or that intrinsically contained a lot of silicon," Kuroda says. "If a thorough testing of various media sold in the U.S. identifies a few that contain higher amounts of silicon, those could become an investigative clue."

Millions of H1N1 vaccine doses may have to be discarded/ WP

From the WaPo:

Despite months of dire warnings and millions in taxpayer dollars, less than half of the 229 million doses of H1N1 vaccine the government bought to fight the pandemic have been administered -- leaving an estimated 71.5 million doses that must be discarded if they are not used before they expire...(and 25 million to be donated to poor countries)...

The World Health Organization, meanwhile, faces mounting charges that it overreacted to the pandemic. The Council of Europe's Parliamentary Assembly is investigating allegations that the Geneva-based arm of the United Nations was influenced by pharmaceutical companies to exaggerate the risk, thereby helping in vaccine sales...

WHO officials have strongly disputed the charges, saying the response was vital given the uncertainty about the new virus and its potential threat. Many independent public health experts have defended the agency.

Nevertheless, the WHO has launched an internal review of its response and announced Monday that a committee of 29 outside experts (chosen by WHO, however--Nass) would conduct an independent assessment. The critique will include whether WHO's pandemic alert system should consider the severity of a new virus, not just whether it is novel and spreading globally.

"Could we have made decisions better? Could we have considered things in a different way at the time?" said Keiji Fukuda, WHO's top flu official, told reporters Monday. "We, along with many others, are asking the same kinds of questions of ourselves and each other...

Internationally, officials are concerned because the virus has started spreading widely for the first time in some parts of the Southern Hemisphere, especially in poor African countries with limited resources to stem the spread and treat cases.

Gulf War Veterans: The VA Takes Important First Steps

by: Paul Sullivan and Anthony Hardie, t r u t h o u t | Op-Ed.  Excerpts follow:

Last week, the US Department of Veterans Affairs (VA) officially recognized several diseases as linked with deployment to the 1991 Gulf War...

As Gulf War veterans, we applaud the VA's proposed new regulations that streamline access to disability benefits for Gulf War, Iraq war and Afghanistan war veterans.

More importantly, the VA's new policy opens access to urgently needed free VA health care for the lingering, disabling health outcomes of these terrible diseases.

The VA's recent decisions were made possible by VA Secretary Eric Shinseki and his Chief of Staff, John Gingrich, a fellow Gulf War veteran. The new regulations, prompted by Gulf War veterans' advocates and the VA's internal Gulf War Veterans Task Force, will impact more than 3.3 million people - the 700,000 veterans of the 1991 Gulf War, the 400,000 veterans deployed to Southwest Asia between 1991 and 2001 plus the 2.2 million who deployed to the wars in Afghanistan and Iraq.

We also applaud the VA's simultaneous decision to expand approval of veterans' disability claims for undiagnosed and ill-defined illnesses which affects at least 25 percent, or up to 210,000, of our Gulf War veterans.

For the historical record and for the new VA's leaders, we hope you understand our cautious optimism:

• The VA fought against Gulf Research, health care and benefits legislation in 1994 and 1998.
• After the laws were passed, the VA still fought against implementing them.
• The VA took four years to create the mandated Research Advisory Committee on Gulf War Veterans' Illnesses until caving to fierce Congressional and veteran advocacy.
• The VA managers intentionally refused to notify about 15,000 Gulf War veterans of a 2001 law that expanded access to benefits and health care.
• The VA staff manipulated the scope of the Institute of Medicine scientific research reviews to specifically exclude certain types of studies for consideration for health care and benefits. Specifically, the VA excluded lab animal studies linking depleted uranium (DU) with birth defects and cancer.
• Last year, the VA impeded and then canceled a Congressionally mandated contract for unparalleled Gulf War illness research at the University of Texas Southwestern (UTSW).
• This year, the VA used the Gulf War research funds designated for UTSW to buy an $11 million piece of lab equipment of dubious value to Gulf War veterans.
• The VA staff still fight against critical research about toxic exposures and medical treatments, thus impeding our efforts to obtain health care.

If we as a nation are serious about providing justice to our Gulf War veterans, then the new VA has taken a few very positive first steps. In order to prevent future obstruction of health care for veterans returning home from Iraq and Afghanistan, then the military has a legal and moral obligation to immediately shut down the use of burn pits overseas. The VA must also provide medical exams to our all returning troops and begin longitudinal studies.

When our government takes these steps, then we will have more confidence it is truly heading in the correct direction.

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??

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:

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.

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.

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.

HOLT DEMANDS OBAMA ADMINISTRATION SUPPORT FURTHER AMERITHRAX INVESTIGATION

FOR IMMEDIATE RELEASE


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

HOLT DEMANDS OBAMA ADMINISTRATION SUPPORT FURTHER AMERITHRAX INVESTIGATION

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
Director
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.

Sincerely,

RUSH HOLT

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...

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.)

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.”

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...

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.

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.

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

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

By Maggie Fox, Reuters. Excerpts:

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.

UNUSED VACCINES

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."

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.”

HOLT CALLS FOR CONGRESSIONAL INVESTIGATION INTO FBI HANDLING OF ANTHRAX ATTACKS

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.