Critically important piece on biopreparedness: How Ready Are We for Bioterrorism?/ NY Times

Here is another blog post coming from the long NY Times article on our government's response to the threat of bioterrorism.  This article is brilliant in its simplicity.  It simply covers the field.  The author interviewed over 100 people who work in biodefense, and he makes clear that the $60+ billion spent on bioterrorism efforts since 2001has not been well spent.  To say the least.  Excerpts and commentary follow.

... And a report by the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, formed in 2007, concluded: “To date, the U.S. government has invested most of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. The commission believes that it should make the more likely threat — bioterrorism — a higher priority.”

This refers to the fact that the USG has failed to pursue the most obvious way to protect Americans from bioterrorism:  adding teeth to the treaty banning biological weapons.  The 1972 treaty bans biological weapon production and use, but lacks any inspections or sanctions, making it almost imposible for the treaty to be enforced.

... After spending hundreds of millions of dollars, for example, to develop a new vaccine for anthrax that would replace the controversial formula developed 50 years ago by the Army — which is known to have serious side effects and has never been approved for children — there is still no new vaccine.

The anthrax vaccine manufacturer is unique in the amount spent on lobbying, and is also unique in the 300% markup it receives for the vaccine over the cost of production.

... Last year, two separate review boards evaluated the state of the country’s biodefense program, and each report came back scathing. The National Biodefense Science Board, a nonpartisan task force created in 2006 to oversee countermeasure development, delivered a 103-page report to the secretary of Health and Human Services, Kathleen Sebelius, describing “lack of urgency,” “lack of coherence,” “lack of prioritization” and “lack of synchronization.” The title of the report was “Where Are the Countermeasures?” And the commission created by Congress in 2007 to evaluate all defenses for chemical, biological, radiological and nuclear threats delivered its final report, offering letter grades in several categories. For attention to the safe storage of toxins, the government received an A. For openness and transparency, a B-minus. For biodefense, the grade was an F.

... Even within the biodefense community, there is a widespread sense that the countermeasure program is failing. Early this year, Sebelius described the effort as “full of leaks, choke points and dead ends,” and in more than 100 interviews with senior officials from each of the federal agencies related to countermeasure development — including past and current program heads at the White House, the Pentagon, the National Institutes of Health and the Departments of Homeland Security and Health and Human Services — I heard an endless series of grim diagnoses on the health of the nation’s biodefenses. As one senior official in the Obama administration put it: “We need a new model. This is never going to work.”


... Officials at Health and Human Services were also determined to produce and store a large supply of anthrax vaccine, but they were unsatisfied with the existing formula. Some veterans blamed the vaccine for gulf war syndrome, citing research at Tulane University, and after vaccination was made mandatory in 1998, hundreds of service members actually refused the shots. Some resigned from service in order to avoid it; a few were court-martialed for insubordination. In 2002, the most comprehensive study of the vaccine, by the Institute of Medicine at the National Academy of Sciences, concluded that while the vaccine was “reasonably safe,” a new vaccine was “urgently needed.”

Executives at Emergent acknowledge the campaign against VaxGen but say it was not directed at the company so much as the structure of the BioShield contract. “Our issue was not with respect to VaxGen,” the president of Emergent, Daniel Abdun-Nabi, told me. “It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country.” According to Abdun-Nabi, the company’s message to legislators was: “You shouldn’t put all your eggs in one basket. There’s a role for multiple suppliers.” The fact that this lobbying contributed to the implosion of VaxGen and another five years in which Emergent was the only supplier of anthrax vaccine, which has earned the company $1.5 billion, also troubles Abdun-Nabi, he said. “It puts us in a very difficult position to be the sole supplier. I mean, the whole nation is reliant on Emergent. And in one sense, we’re very honored to be in that position, but it’s a tremendous responsibility.”

General Russell, who led the early countermeasure program, told me: “It was Emergent lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen.” Several current officials share Russell’s view. When I asked one senior biodefense official about the lack of a new anthrax vaccine, the official nearly exploded: “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying!” 

"Emergent bought the Congress."  You saw it in the NY Times.  A poisonous vaccine, for which you can't get the CDC data or the military data on safety (data collected at taxpayer expense), has been stockpiled for the American public.   At a total cost of about 2.5 billion dollars.  The threat of bioterrorism has been used to justify enormous expenditures for a vaccine nobody wants to receive.

The latest scam proposed to test the vaccine in children, to expand the vaccine indications.  (Anthrax vaccine is not currently approved for those under 18 or over 65.)  Both Republican and Democratic administrations have supported mandatory anthrax vaccinations. The last (Bush) administration approved the vaccine for civilian first responders.  The Obama administration proposed testing the vaccine in children.  Money seems to be one of those things that ignores party lines.

UPDATE:  However, the public seems to have had enough of business as usual in Washington.  According to the Nov 1, 2011 NY Times:

According to a New York Times/CBS News poll in September, only 33 percent of registered voters believe their own member deserves to be re-elected, and a mere 6 percent said the same about most members of Congress, both the lowest figures since The Times started asking this question in the early 1990s.

The anthrax vaccine boondoggle/ Forbes

Thanks to author Steven Salzberg, who worked sequencing anthrax for the FBI letters investigation, writing in Forbes:

The anthrax vaccine is a truly bad idea. The U.S. has wasted billions of dollars on it, and it just seems to go from bad to worse. Now a government panel has recommended that we test the vaccine on children, which raises a whole new array of ethical questions.
Don’t get me wrong: vaccines are the greatest boon to public health of the last 200 years. We eradicated smallpox, we’re close to eradicating polio, and childhood deaths from infectious diseases are far, far lower thanks to the vaccines we give our children. These are truly wondrous advances.
But the anthrax vaccine is different, from start to finish.
For starters, anthrax is not infectious. [What he is trying to say is that it is not contagious from person to person.  It is, however, infectious, in that it does infect people and animals--Nass]   This might come as a surprise to those who’ve only heard about this through the media. An anthrax “outbreak” is impossible, because the B. anthracis bacterium cannot spread from person to person. Vaccines against diseases such as measles, mumps, and influenza protect millions of people each year, because these are common infectious diseases that spread easily between people.
Anthrax was never a public health threat, and it isn’t one now. We don’t need an anthrax vaccine. And by developing and then promoting one, the government is abusing the good will that the public has towards vaccines, possibly endangering the public health further by playing into the hands of the anti-vaccine movement.
The Centers for Disease Control (CDC) does not recommend that children be vaccinated against anthrax. In fact, it doesn’t recommend that anyone get routine vaccinations against anthrax:

“Vaccination is recommended only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely.”

The CDC recommendation makes sense. Therefore I was stunned to learn this week that the National Biodefense Science Board (NBSB) recommended that we launch an anthrax vaccine testing program in children (see page 37 of their report).
The NBSB report admits that

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”

It also states that

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”

Case closed, right? We can’t conduct vaccine trials in children if there’s no benefit.
Somehow, though, even after these statements in their own report, the NBSB managed to recommend testing the vaccine in children. As justification, they present this claim:

“Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.”

This is a massive overstatement. A national and global threat? Anthrax is not infectious, as the NBSB knows. The only people affected in an attack would be those directly exposed to the bacterium, likely only a handful of people. We don’t vaccinate millions of people just to protect a hypothetical few: this is an abuse of the public trust in vaccines.
So why are we wasting billions of dollars to develop, test, and administer a vaccine against something that hardly infects anyone? The anthrax vaccine development project was on its way to being cancelled by the U.S. before the 2001 anthrax attacks. In an ironic twist, the likely perpetrator of the attacks, Bruce Ivins, was allegedly motivated by his interest in reviving the anthrax vaccine program. If so, then he succeeded in a big way: in 2004, the government announced Project Bioshield, which dedicated $5.6 billion to biodefense, much of that going to anthrax vaccine research.
I’m not surprised that if the government dedicates billions of dollars to biodefense, and distributes it to companies and universities who then become dependent on these funds, then advisory panels such as the NBSB will recommend an ever-increasing number of security measures. After all, some of the members of that committee are funded by biodefense dollars, and if we cut the funding, their own livelihoods might suffer.
Speaking to the Washington Post, panel member Ruth Berkelman said:

“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack.”

No, we don’t. We don’t need to know about the safety of the vaccine in children because it would be unethical to test it on them. And if there is an attack, we shouldn’t respond by vaccinating “a large number of children,” because anthrax doesn’t spread from person to person. This is one vaccine we can do without.

CDC's Withholding Information on its Civilian Anthrax Trial is a Travesty

Why did the most important trial to have been conducted on anthrax vaccine safety (by CDC between 2002 and 2007, with 1564 civilian subjects) only publish an interim report, and never discussed the 229 serious adverse events reported in trial participants?  The trial tested serologic efficacy also.  The investigators published partial data in JAMA on October 1, 2008, but only for the first 7 months of a 43 month trial, and only for 2/3 of the subjects.

  

The 2008 data were used to reduce the initial vaccine course from 6 to 5 doses, and to switch from subcutaneous to intramuscular doses.  Within 4 weeks of publication, DHHS bought 14 million more doses of vaccine, in addition to about 25 million already stockpiled, and CDC's Advisory Committee on Immunization Practices (ACIP) approved anthrax vaccine for first responders.  An earlier 2000 ACIP report had recommended against use in groups for whom a risk-benefit calculation could not be made:

"Although groups initially considered for preexposure vaccination for bioterrorism preparedness included emergency first responders, federal responders, medical practitioners, and private citizens, vaccination of these groups is not recommended. Recommendations regarding preexposure vaccination should be based on a calculable risk assessment. At present, the target population for a bioterrorist release of B. anthracis cannot be predetermined, and the risk of exposure cannot be calculated. In addition, studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled B. anthracis spores (28,83). Because of these factors, preexposure vaccination for the above groups is not recommended. For the military and other select populations or for groups for which a calculable risk can be assessed, preexposure vaccination may be indicated."  

Although the final CDC trial results, carefully collected during about 20 clinic visits for each subject, have not been released:

1. a federal advisory committee voted in favor of testing the vaccine in children, 
2. an additional $1.25 billion worth of anthrax vaccine was purchased for the civilian stockpile 3 weeks ago (44.75 million doses), 
3. the decision to approve use of the vaccine in civilian first responders were all made without these data.  

All 3 decisions were made by DHHS agencies or their advisory committee, while a DHHS agency withheld the most important scientific evidence about vaccine safety and serologic efficacy.  Is there any rational, scientific or ethical justification anyone can make for how DHHS can behave like this?  How can anyone claim the Department of Health and Human Services is acting in the public good?

The real question is who gave DHHS its marching orders, and what did they get in return?

Congress ordered a civilian trial of anthrax vaccine in 1999, yet 12 years later we have thousands of injured people, but the CDC data on anthrax vaccine safety has not been shared with the public, though it was publicly funded.

Do the data so challenge government policy that they have to be hidden?  How could any policymaker, knowing this cache of data exists, not demand it before buying $1.25 B worth of vaccine, or proposing vaccine for first responders, and then children? 

The principal investigator of this trial for CDC is veterinarian Jennifer Wright.  Jennifer briefed the ACIP (with significant omissions), leading to their vote in 2008 in favor of first responder vaccinations.  Before Jennifer, veterinarian Nina Marano at CDC was in charge.  It seems relevant that veterinarians supervised a human clinical trial; MDs have different ethical obligations than veterinarians.

The following quote from the journal Nature is about the controversial early release last week of data from a malaria vaccine trial.  It makes clear that the release of the very early CDC anthrax vaccine data was odd, and failure to publish the final data  unacceptable, for a trial that ended 4 years ago.  CDC would have us accept the cherry-picked preliminary data as the last word on this trial.  We must demand the real thing. 

"Some researchers question whether the results should have been published before all the data were available; full results are expected in 2014. Interim trial data are usually reported only to regulatory authorities, and clinical trials published only once all the data are in, noted Nicholas White, a malaria expert at Mahidol University in Bangkok, in an editorial³ accompanying the interim results. "There does not seem to be a clear scientific reason why this trial has been reported with less than half the efficacy results available," he wrote."

No anthrax vaccine testing on children — for now/ AP

I decided to just say briefly what happened yesterday at the NBSB conference call.


Every member of the NBSB, with the exception of Iowa's top public health officer, Patricia Quinlisk, MD, voted in favor of testing anthrax vaccine in children.  Kudos to Dr. Quinlisk for making clear that her public health background precluded agreement.


Panel member Ruth Berkelman suggested that a sentence be added to the recommendation, asking for a national ethics board to review the trial.  Her suggestion was tweaked slightly and accepted by all.  Were the panel members relieved to add another layer of review?


Whether the Presidential Commission for the Study of Bioethical Issues or a newly created panel would serve as the ethical-legal reviewing body is uncertain.  Vera Sharav, president of the Alliance for Human Research Protection, and I remain of the opinion that the trial is legally unapprovable under the language of 46 CFR 45 Subpart D which would require:

the Secretary ...determines that the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting children’s health or welfare, and, in addition, determines that the research will be conducted in accordance with sound ethical principles and that adequate provisions are made for soliciting the assent of children and permission of their parents or guardians as discussed in 46.408.

Sound ethical principles, of course, means you have to tell the truth about what is known regarding safety and efficacy of this vaccine, and furthermore, tell parents that the HHS secretary has given anthrax vaccine a PREP Act waiver, and the manufacturer cannot be sued for damages.


Reader comments appended to the online news articles about the meeting (Google says there are 289 articles) almost uniformly pan the vaccine trial.  The most frequent comments have to do with whose children should be those tested first:  those of panel members, DHHS officials, Congress or Obama.  It seems everyone except the professionals understands this trial involves human sacrifice, regardless of media reports that the vaccine has been sufficiently tested in adults.


In the end, Assistant DHHS Secretary Lurie told the panel that the department would decide whether to follow their advice, and when.  "We're not ready to make a decision at this time but will continue the dialogue," Lurie said. 


To me she sounded lukewarm.  For the first time, the issue of "finding the money for the trial" came up.  Reading between the lines, I heard, 'this seemed like a good idea at the time, but with an election coming up, we don't need to antagonize yet another constituency.'  If self-preservation is the strongest impulse of a bureaucrat, I don't see Lurie authorizing this trial in the next 12 months.  Maybe never:  if it bombs, she'll take the fall.


On the other hand, there is a lot of money involved, with a new contract inked on October 3 by DHHS for an ADDITIONAL $1.25 BILLION anthrax vaccine for the civilian stockpile.  Always follow the money.  DHHS didn't ask where it was going to find the money for that in the federal budget.

NY Daily News Polling Readers on whether anthrax vaccine should be tested in children

 

From the Daily News:  Take our Poll

Poll Results

Do you think an anthrax vaccine should be tested on children?

Yes	11%
No	80%
Not sure	8%

Reforms Seen Failing to Rescue U.S. Biodefense Drug Efforts/ GSN

From the NY Times, adapted by Global Security Newswire:

... The nation's preparations for a biological strike face numerous challenges, according to more than 100 interviews with high-level officials at participating federal entities such the National Institutes of Health and the White House, as well as the the Health and Human Services, Defense and Homeland Security departments.
Industry specialists have pointed to possible political motivations behind the 2006 cancellation of a deal for development of a new anthrax vaccine, shortly after the creation of a new Health and Human Services Department office intended to facilitate the creation of such treatments. In addition, the National Strategic Stockpile of medical countermeasures still lacks vaccinations for any potential biological "material threats" beyond anthrax and smallpox, and production of no such vaccine is slated to begin in the near future.
The National Biodefense Science Board in a 2010 report said a "lack of U.S. capability to rapidly recognize, respond and recover from a biological attack is the most significant failure" found during the assessment. “Especially troubling is the lack of priority given to the development of medical countermeasures -- the vaccines and medicines that would be required to mitigate the consequences of an attack.”
Health and Human Services Secretary Kathleen Sebelius earlier this year said the countermeasure program was “full of leaks, choke points and dead ends."
A high-level Obama administration source added: “We need a new model. This is never going to work.”
The 2001 anthrax mailings prompted an increase in biological defense funding from $633 million to $4 billion the following year, with a focus on adding to a medical countermeasure cache established in the late 1990s that comprised primarily of 15 million smallpox vaccinations as of mid-2001.
The National Institutes of Health and numerous independent scientific groups in the United States pushed from 2001 until 2004 to refine new manufacturing procedures and expand the stockpile of vaccine for smallpox, a disease eradicated from nature that is known to spread readily and result in death for roughly every third person infected. The United States now holds in excess of 300 courses of smallpox countermeasures in the Strategic National Stockpile.
Still, a $5.6 billion funding tranche unveiled by the Bush administration in 2003 for the development of new biological-weapon countermeasures was insufficient for initiating development of a next-generation anthrax vaccine by the following year, officials said...

Later that year [2006], though, the Health and Human Services Department indicated it would terminate a deal with the biotechnology firm VaxGen for development of a new anthrax vaccine. Issue experts have continued to dispute what prompted the move. One target of blame has been Maryland-based Emergent BioSolutions, which produces the only anthrax vaccine now licensed by the Food and Drug Administration.
“It was [Emergent BioSolutions] lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen,” said Philip Russell, a one-time head of the Army Medical Research and Development Command. “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying.”
“They bought the technology and buried it,” Russell added. “We are five or six years behind where we should be. We should be working on a third-generation vaccine.”
“Should we have kept it? I think there’s a long debate,” BARDA head Robin Robinson said in reference to the canceled vaccine project. “They had brought in some really top-flight people in there, and [former VaxGen head] Lance Gordon was really good at judging talent. Unfortunately, there was a lot of political pressure.”
Countered Emergent President Daniel Abdun-Nabi: "Our issue was not with respect to VaxGen. It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country." [Emergent btw is a single supplier with an unproven technology--Nass]
Meanwhile, the BARDA office has only received small portions of its intended $1 billion yearly budget.
“What does it take in the pharmaceutical industry?” Health and Human Services Assistant Secretary Nicole Lurie asked in 2009. “A billion dollars per product! The advanced development part of that might be about $350 million, so that’s the part that we should be funded for.”
The office has received additional funding since 2009, but some firms have described organizational complications created when Lurie asked contractors to coordinate with her rather than Robinson.
“Now you really have two bosses,” said Eric Richman, chief executive offerer of PharmAthene, one of four firms working on a potential successor to the anthrax vaccine. “We actually spend as much time managing our contracts as we do developing our drugs. It’s a real burden.”
“This becomes very frustrating for [Robinson],” one HHS official added. “What does he tell the companies -- ‘Now I have to go ask for permission?’”
Lurie and Robinson also provided diverging explanations for the agency's move way from vaccine development in favor of drugs that are potentially usable against multiple agents.
Lurie described said the move was prompted by budgetary concerns. “You’d like to have vaccines further along in the pipeline for all the threats we have, and you’d like to have a way to manufacture them quickly,” Lurie said. “But I don’t think there’s anywhere near enough money in the system.”
Robinson, though, said the changing emphasis was motivated by the questionable medical feasibility of vaccines for additional agents. “There are only two biothreats -- smallpox and anthrax -- that we feel vaccination is the appropriate way to go,” the official said.
“I don’t think there’s a case to be made for" vaccines for other bioterror threats, he said. "What we’re doing is therapeutics.”
That position was questioned by Tara O’Toole, who heads the Homeland Security Department's Science and Technology Directorate. “Vaccines are essential. If there’s a bioattack, people are going to want their children vaccinated. It’s the only defense against reload.”
Former Navy Secretary Richard Danzig elaborated on the "reload" idea: “When we talk about terrorists’ acquiring a nuclear weapon, we’re talking about just that -- they’re acquiring a weapon. With biological weapons, we’re talking about acquiring the ability to produce weapons. So if you acquire the ability to produce 100 grams of anthrax, you can keep doing that. You really have to think about biology as potentially the subject of a campaign, where somebody keeps attacking, rather than a one-shot incident.”
“You can reassure people that there will be antibiotics available for them, and you can keep producing ever greater numbers of antibiotics. But you can see that if you had the ability to vaccinate people and protect them, it would provide a larger degree of protection. So to the extent that these things come to pass, I think there will be more pressure to develop vaccines,” Danzig said.
Brett Giroir, a former head of the Defense Sciences Office at the Pentagon's Defense Advanced Research Projects Agency, also endorsed the development of vaccines for a wider range of threats.
“Vaccines are critical components of a biodefense posture, and anybody who thinks they’re not isn’t thinking seriously about how we approach this,” Giroir said. “If we got sprayed with tularemia in College Station [Texas] and a biodefense sensor went off, that would be an ideal opportunity for vaccine.”
Fauci questioned the practicality of the "material-threat" list.
“It’s less of a priority to say, ‘OK, now here’s our menu for the Strategic National Stockpile,’” he said. “We call that the military model.”
“Do we have this little thing in the stockpile or not? I don’t judge the safety of the country on that basis. To me, the idea of a naturally occurring threat is infinitely greater,” he said.
The official described the list as a remnant of Cold War-era planning for a biological strike by the Soviet Union.
“So when the decision was made to make an investment into developing countermeasures,” Fauci said, “that was essentially their matrix from the beginning: these are what we know the Soviets had. We know they have stockpiles. This is what we’re going to protect against.”
“I think the unknown threat of a mutant microbe is infinitely greater than someone coming and dropping a glanders on us,” he said. “I mean, seriously. Get real about that.”
O'Toole said Fauci's remarks were "completely wrong" regarding the list.
“We use current intelligence as an integral part of every material-threat determination,” the official said. “I’m surprised anyone in NIH would think otherwise, particularly since the details of the material-threat determination process are briefed at the White House. It does raise a troubling question about how seriously NIH is engaged in the biodefense mission.”

The absence of one person at the White House who would work solely on biological readiness matters is another concern, according to past and present officials. Currently, four top White House staffers have some level of involvement on the issue while also dealing with other matters, according to the Times (see GSN, Oct. 19).

“The only way that you can get all of those people in the room is to call them into the White House, and to have a coordinating group under a single person,” said Kenneth Bernard, a health security specialist for the Clinton and Bush administrations.
Randall Larsen, chief executive officer of the WMD Center, described a lack of a central coordination as a problem.
“Today, there are more than two dozen Senate-confirmed individuals with some responsibility for biodefense. Not one person has it for a full-time job, and no one is in charge” (Wil Hylton, New York Times, Oct. 26).

Lantana anthrax widow settles $50 million lawsuit against federal government

From the Palm Beach Post:

... While he is legally prohibited from revealing much of what he learned and many of the court documents are sealed, Weisser said he was stunned by the lack of security at the lab. In court papers, the government conceded that before the attacks, Fort Detrick didn't have cameras to monitor the labs and didn't search workers for pathogens when they were leaving the base...

Attorney Jason Weisser said he couldn't divulge the terms of the settlement until it is formally approved by the U.S. Justice Department...

UPDATE:  Judge to hear arguments on unsealing documents in this case.

NBSB urges pre-attack studies of anthrax vaccine in kids/ CIDRAP

From the NY Times, adapted by the Center for Infectious Disease Research and Policy, U Minnesota:

Oct 28, 2011 (CIDRAP News) – An expert advisory panel today approved a recommendation that the US Department of Health and Human Services (HHS) develop a plan to study the use of anthrax vaccine in children before an attack with Bacillus anthracis.

A National Biodefense Science Board (NBSB) working group presented a draft of its final report to the full board today during a public teleconference. It weighed the pros and cons of gathering safety and immunogenicity data about the anthrax vaccine either before or after an attack.

The NBSB working group advises the federal government on biodefense countermeasure issues.

Before the vote, board members had the opportunity to voice their support or concerns. Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta, said she agreed that data are needed before a bioterror event, but noted that the science arguments collide with ethical issues.

Though she said the working group was sensitive to ethical issues, she proposed that the group's recommendation be forwarded to an appropriate group for additional ethical consideration. The board tweaked its recommendation to include Berkelman's suggestion.

John Grabenstein, RPh, PhD, senior medical director for adult vaccines at Merck, said he has served on ethics review boards for about 20 years. "Kids are recognized as a vulnerable population, and there are special requirements to protect them," he said. "I'd rather know what the response is before the vaccine is offered to many, may kids."

The report's recommendations support the writing of a good protocol that would give parents a lot of information and plenty of time to consider all the aspects of a pre-event study, he added.

In April Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response (ASPR) at HHS, asked the NBSB's anthrax working group to explore complex scientific, ethical, legal, and regulatory issues related to pediatric anthrax vaccination. The group held a public engagement meeting in July, and in September presented the report's executive summary to the full board and fielded comments from the public.

Anthrax vaccine adsorbed (AVA) has been used in about 2.5 million military members, so researchers are more familiar with the vaccine's safety and immunogenicity profiles in adults. Though US bioterror response plans say both adults and children should receive three doses of the vaccine with antibiotic prophylaxis after an anthrax attack, no studies have been conducted in children, which make up about a quarter of the US population.

During the public comment part of the meeting, members of the public strongly opposed the NBSB's recommendation, while others spoke in favor of it. Vera Sharav, with the Alliance for Human Research Protection, told the group that there is no evidence that anthrax is a threat that affects US children, and she accused the board of making the decision to protect vaccine company profit margins.

Meryl Nass, MD, an internist who has studied anthrax vaccine injuries and bioterror issues, said she believes the US public is almost unanimously against pursuing anthrax vaccine studies in children in advance of a bioterror attack. "But the people inside the beltway see things differently," she added.

However, Steve Krug, MD, a pediatrician and emergency physician in Chicago, said he took part in the NBSB's public engagement session in July. "The ethical issues are very pertinent, but I support the recommendations of this working group," he said.

The report and recommendation passed by a 12 to 1 vote. Patricia Quinlisk, MD, MPH, the board's chair, opposed sending the recommendation to HHS. "My background has influenced how I feel. I don't know if a pre-event option is the appropriate response," she said during the comment period before the vote. Quinlisk, a microbiologist and epidemiologist, is medical director for the Iowa Department of Public Health and has served on a host of vaccine safety and bioterror advisory groups.

After the vote, Lurie said she wanted to make sure the public knows that the NBSB is an advisory body and that its recommendations are not binding. She said the issue of studying the anthrax vaccine in children is very complex, and she predicted that dose-sparing studies being conducted in adults will have affect AVA issues related to children.

"We're not ready to make a decision at this time but will continue the dialogue," Lurie said.

Other stories about this can be at the Washington Post, Science and Fox.

Current Vaccine Safety Concerns: Preflucel

From the Scottish Press and Journal:

Don't panic, says Scottish government probe launched into drug batch

Flu vaccine doses recalled in scare over side effects

The Scottish Government is recalling thousands of flu vaccines over fears that the drug is making some people ill, the Press and Journal can reveal.

About 300,000 doses of Preflucel are being withdrawn immediately from surgeries and pharmacies across the UK and Europe.

Health chiefs have warned that one of the most recent batches, issued at the beginning of September, is causing more side-effects – muscle pain, headaches and fatigue – than previous vaccines.

They have been recalled while its manufacturer and the Medicines and Healthcare Products Regulatory Agency investigates what has gone wrong.

Doctors and nurses in Scotland – where 2,500 vaccines have been recalled – have been told not to use any Preflucel until further notice.

How critical is it to test drugs and vaccines in kids before giving them to kids?

According to the FDA:

As of 2008, an estimated 50 to 60 percent of prescription drugs used to treat children have been studied in some part of the pediatric population. Still, the likelihood that a medicine has actually been studied in neonates—children less than a month old—is close to zero.
So nearly a decade into the 21st Century, most medicines intended for children, including many over-the-counter (OTC) products, haven’t been clinically studied in children—and certainly not in all age populations that comprise the branch of medicine known as “pediatrics.”

 In other words, we "guesstimate" pediatric doses most of the time.  Guesstimating an anthrax vaccine dose, particularly since we have tested the vaccine in many small monkeys, would not be a stretch from standard pediatric practice.

1-2% of those receiving anthrax vaccine have had serious adverse events: Milvax and Vaccine Healthcare Centers

Possible study of anthrax vaccine’s effectiveness in children stirs debate/WaPo

The people on the NBSB could only come up with a recommendation to test anthrax vaccine on children if they were ignorant about the vaccine and/or the law's requirements for testing children under 45 CFR 46.407.  I will have much more to say about this unfolding story over the next few days.  Here is Rob Stein's comprehensive WaPo piece, with my comments in italics:

The Obama administration is wrestling with the thorny question of whether scientists should inject healthy children with the anthrax vaccine to see whether the shots would safely protect them against a bioterrorism attack.

The other option is to wait until an attack happens and then try to gather data from children whose parents agree to inoculate them in the face of an actual threat. [Every child exposed in 2001 got antibiotics and survived.  The CDC designed a child consent form in 2001, offering the vaccine to children and hoping for takers, but parents were too smart to volunteer their children when there was an actual event and a safer alternative.--Nass]

A key working group of federal advisers in September endorsed testing, sparking objections from those who consider that step unethical, unnecessary and dangerous. The National Biodefense Science Board (NBSB), which advises the federal government, is to meet Friday to vote on its working group’s recommendation.

“At the end of the day, do we want to wait for an attack and give it to millions and millions of children and collect data at that time?” said Daniel B. Fagbuyiof Children’s National Medical Center in Washington, who chaired the group. “Or do we want to say: ‘How do we best protect our children?’ We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children.” [The vaccine has not been approved for those over 65, so Gramps cannot legally obtain the vaccine.  Why does this working group co-chair not know this?  And why not test in those over 65 before subjecting children who cannot provide informed consent, to a vaccine that could leave them with a permanent injury?--Nass]

The vaccine has been tested extensively in adults and has been administered to more than 2.6 million people in the military. But the shots have never been tested on or given to children, leaving it uncertain how well the vaccine works in younger people and at what dose, and whether it is safe. Unlike with measles, mumps and other diseases, the chance that children will be exposed to anthrax is theoretical, making the risk-benefit calculus of testing a vaccine on them much more questionable.

“It’s hard to believe that it’s something that makes a great deal of sense,” said Joel Frader, a pediatrician and bioethicist at Northwestern University’s Feinberg School of Medicine. “It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack.”

Anthrax is a life-threatening infection caused by a toxin-producing bacteria long considered a bioterrorist’s likely choice because it is relatively easy to produce and distribute over a large area. A week after the Sept. 11, 2001, attacks, letters containing anthrax spores arrived at several media offices and two Senate offices, killing five people and sickening 17 others. The FBI eventually concluded that the letters were mailed by Bruce Ivins, a disgruntled scientist at Fort Detrick in Maryland who committed suicide in 2008, although some experts question the FBI’s findings.

As part of broad effort to better protect Americans against bioterrorism, the Pentagon began a controversial military anthrax immunization program in 1998 that was challenged in court over questions about the vaccine’s safety and reliability. Currently, the Pentagon requires the shots for personnel assigned to bioterrorism defense activities and some other special units, as well as those deployed 15 or more days in the Middle East and some nearby countries, and in South Korea.

The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. Antibiotics would help protect those immediately exposed. The vaccine would defend against lingering spores, which is how the pathogen lurks in a dormant state. The vaccine is made from a piece of a strain of anthrax that doesn’t cause the illness.  [The government spent an additional $1.25 billion for extra anthrax vaccine to protect civilians on October 3, 2011.  Anthrax vaccine expires in 3 years, and requires yearly boosters after an initial 5 doses, guaranteeing a captive market for the foreseeable future.  Did I mention the vaccine's 300% markup?--Nass]

In April, Nicole Lurie, the assistant secretary in charge of bioterrorism at the Department of Health and Human Services, asked the 13-member biodefense board to evaluate whether the vaccine should be tested in children. A federal simulation of an anthrax attack on San Francisco, called Dark Zephyr, raised quesions about how to handle children.
“If there were an anthrax release and we needed to administer anthrax vaccine, we have no experience with kids. It’s never been in the arm of a kid,” Lurie said. “I started asking myself, ‘Is this the right way to respond in an emergency?’ ”  [The more germane question is whether anthrax vaccine provides a high degree of protection in humans.  We don't have the answer for adults yet, and this trial won't tell us if it works in children.  Studies have repeatedly shown that antibody levels (in many animal species) generated by this vaccine fail to predict survival.  Since this trial can only measure antibody levels, it will be unable to predict survival.  Therefore, it cannot generate useful information on dosing in children.--Nass] 

Those concerns were heightened by the public wariness that had been shown toward the H1N1 influenza pandemic vaccine.  “There is a lot of skepticism on the part of the public about vaccines in general,” Lurie said. “If you had a situation where a vaccine has never been given to a child, it’s pretty hard to think what you could say to people about its safety and efficacy.” [Funny, the CDC knew what to say back in 2001--Nass]

But testing drugs and vaccines in children is problematic. Parents generally are allowed to let their children participate in studies only if they would face minimal risk or would be likely to benefit directly or indirectly in some way.

“With this, you’re putting children at risk for no clear scientific or medical benefit,” said Meryl Nass, a doctor in Bangor, Maine, who is one of the most outspoken critics of testing the vaccine in children. Nass and others maintain that there are serious questions about the vaccine’s effectiveness in adults as well as concerns about sometimes serious complications among those vaccinated in the military. A variety of complications have been reported, including nervous system and autoimmune disorders, Nass said.

“Really, the core question is ‘Why? Why test?’,” said Bruce Lesley, president of First Focus, a Washington-based advocacy group for children. “We don’t want to be subjecting kids to risks needlessly.”

Some question the value of a study, saying that testing in animals indicates it will be difficult to determine what level of immune system response will be protective.
“What exactly are we going to learn?” said Vicky L. Debold, an associate professor of health administration and policy at George Mason University. “We’ll know what antibody levels these infants produce, but do we know those antibodies are going to protect against death due to anthrax exposure?”  [Excellent point, since antibody levels are a poor surrogate for survival--Nass]

 UPDATE:  Professor Les Baillie, who directed anthrax research at Porton Down, UK and also worked on biodefense for the US Navy, made exactly the same point in the November 2 New Scientist:  "The proposal is to vaccinate children and measure their immune response, but no one knows what level of immunity will protect humans against infection. "What will these tests show?" Baillie asks."  This is the real question:  what could the trial actually glean of scientific value?  The answer is:  nothing.    A child trial, without exposing children to anthrax, is only a cynical marketing ploy and nothing more.

Back to the Rob Stern WaPo article:

After sifting through the scientific, social and ethical conundrums raised by this question, the eight-member working group concluded that it would be ethically justifiable to conduct a study, which would provide crucial information, such as whether the vaccine is safe and how many doses would be needed.  “A lot of things have happened that we didn’t think could happen. I think the threat is real, and we should be prepared,” said Fagbuyi, an assistant professor of pediatrics and emergency medicine at the George Washington University School of Medicine.  Fagbuyi and others dispute concerns about the vaccine’s safety, noting that the Food and Drug Administration, the National Academy of Sciences and many other independent authorities have concluded that it is as safe as other commonly used vaccines, producing serious complications very rarely.  [This is not actually true.  What happened was that the IOM committee studying anthrax vaccine in 2001 requested a report that made this claim, but there have been NO clinical trials that looked at anthrax vaccine adverse events and compared them to those of other vaccines.  No other licensed vaccines have a 1-2% serious adverse event rate (See slide 3 of this military powerpoint presentation).--Nass]

“Our role is to protect children,” said John S. Bradleyof the University of California at San Diego, who advised the working group on behalf of the American Academy of Pediatrics. “If the military is telling us there is a credible threat, the best way to protect children is to have the data.”  [A 2010 article of Dr. Bradley's indicates:

Potential conflicts of interest. J.S.B.'s employer has received research grants from Johnson & Johnson and Wyeth Pharmaceuticals and holds consultant contracts with Johnson & Johnson, Wyeth Pharmaceuticals, and Bayer Pharmaceuticals.

Supplement sponsorship. This article was published as part of a supplement entitled “Workshop on Issues in the Design of Clinical Trials for Antibacterial Drugs for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia,” sponsored by the US Food and Drug Administration, Infectious Diseases Society of America, American College of Chest Physicians, American Thoracic Society, and the Society of Critical Care Medicine, with financial support from the Pharmaceutical Research and Manufacturers of America, AstraZeneca Pharmaceuticals, and Forest Pharmaceuticals.--Nass]

If the board endorses the recommendation, Lurie will meet with counterparts at the FDA, the National Institutes of Health and other agencies to work out the details, including how many children would be studied, at what ages and doses, and how costs would be covered.
“Because it’s such a heated issue, I’ve tried hard to keep an arm’s length until the board makes a recommendation to me,” Lurie said. “To be honest, the safest and easiest thing to do would be to not make a decision and kick the can down the road. But it seemed to me it that would be socially irresponsible. [By seeing whose children become subjects in this trial, we will see how socially responsible it is.--Nass]  I would hate for a lot of children to die because we didn’t have enough information for the public to feel comfortable getting vaccine.”

A UPI story on this subject is here.

With security spotty, many had access to anthrax at Army lab/McClatchy, ProPublica

Greg Gordon and Stephen Engelberg continue their important series of reports for McClatchy and ProPublica, here focusing on the inadequate security at USAMRIID and potentially wide access to Ivins' anthrax spores by 419 or more people:

The Army laboratory identified by prosecutors as the source of the anthrax that killed five people in the fall of 2001 was rife with such security gaps that the deadly spores could have easily been smuggled out of the facility, outside investigators found.
The existing security procedures - described in two long-secret reports - were so lax they would have allowed any researcher, aide or temporary worker to walk out of the Army bio-weapons lab at Fort Detrick, Md., with a few drops of anthrax - starter germs that could grow the trillions of spores used to fill anthrax-laced letters sent to Congress and the media.
The two reports, which have not been made public for more than nine years, describe a haphazard system in which personnel lists included dozens of former employees, where new hires were allowed to work with deadly germs before background checks were done and where stocks of anthrax and other pathogens weren't adequately controlled.
Fort Detrick since has adopted new bio-security measures. But the security reports by independent government specialists suggest that deadly anthrax stocks may have been more accessible than investigators assumed in declaring Army scientist Bruce Ivins the perpetrator.
The letters, mailed to two U.S. senators and at least three media outlets, panicked the nation in the immediate aftermath of the 9/11 terrorist attacks. The Justice Department says the letter spores derived from a flask controlled by Ivins at Fort Detrick.
Marked "for official use only," the two reports were completed in 2002. One was conducted by a seven-member team from Sandia National Laboratories in Albuquerque, N.M. The other was by auditors for the Army's inspector general's office.
The teams evaluated security at the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID, then the lead federal lab for developing vaccines and other medical defenses against biological weapons.
McClatchy Newspapers, the online investigative newsroom ProPublica and PBS's "Frontline," which have collaborated in an examination of the Justice Department's case against Ivins, obtained copies of both reports.
The reports are expected to be made public later this week in a $50 million lawsuit filed in federal court in West Palm Beach, Fla., by family members of Robert Stevens, a photo editor for American Media Inc., who was the first person to die from the anthrax attacks.
"It's about time," said Richard Schuler, a lawyer for the family. "The public should know about the way security for deadly pathogens was being handled - or mishandled - by the Department of the Army and the government in the period leading up to the 2001 anthrax attacks."
A psychological report on Ivins, who committed suicide in July 2008, said Ivins had "diagnosable mental illness" when he was hired in 1980, and that his mental health should have disqualified him from obtaining a "secret-level" security clearance.
Ivins died of an overdose soon after learning that prosecutors were seeking approval to charge him with five counts of murder. The FBI case was largely circumstantial, although prosecutors say their most direct evidence was the genetic link between anthrax in the letter powder and spores in Ivins' flask of liquid anthrax.

Before posthumously declaring Ivins the killer, the Justice Department said, the FBI eliminated as suspects as many as 419 people. Those individuals would have had access to Ivins' flask, which was stored in an airtight "hot suite" at Fort Detrick, or to spores he had shared with colleagues or outside researchers, including scientists at the Battelle Memorial Institute in West Jefferson, Ohio.
The Sandia report emphasized that terrorists had obtained germs from research labs before. It cited a February 2001 National Defense University study that found 11 cases in which terrorists or other "non-state operatives" had acquired biological agents from "legitimate culture collections," including three research or medical laboratories.
Despite USAMRIID's sobering mission, the Sandia report said, the western Maryland lab had developed a work environment in which employees failed to make the same "indisputable commitment to security" as they did to research.
"The current biosecurity system at USAMRIID does not adequately protect HCPTs (high-consequence pathogens and toxins) and related information," wrote the Sandia team, headed by security expert Reynolds Salerno.
The report said no rules governed movement of germ specimens from one building to another, for example, and that a test tube containing some of Ivins' spores was left for weeks in a refrigerator in a second building.
Fort Detrick's personnel database failed to list 213 of USAMRIID's employees but did include 80 who had left their jobs, the Sandia report said. A separate human resources roster listed 56 people who had left but not 12 who worked there.
Conflicting rosters didn't necessarily signal a security weakness, the Sandia team wrote, but they contributed to "perceived chaos in the personnel system" at the facility.
Even if all those things had been perfect, the examiners said, there was little way to detect diversions from flasks of germs, because a "malevolent" worker could grow more of the pathogen or find other ways to conceal the removal of a small amount.

Asked about the studies, a Justice Department spokesman said in a prepared statement that the FBI looked at everyone who had card-key access to the "hot suites," including researchers with up-to-date vaccinations, then thoroughly investigated "all individuals with theoretical access" to Ivins' spores in advance of the mailings.
The Army auditors, who studied security throughout Fort Detrick, not just at USAMRIID, made clear that pathogens in the bio-weapons facility were "not afforded a standard, minimum level of protection" similar to that for nuclear and chemical weapons.
Although a 22-year-old Army regulation governing the management of hazardous biological substances was in effect in 2001, the Army auditors wrote, two of the three labs at Fort Detrick weren't aware of it and the other ignored it as outdated.
The Army report also said that contractor labs, such as Battelle, had limited regulation and no screening of individuals working with anthrax and other pathogens, creating "the potential for unauthorized access to these materials."

USAMRIID has long since committed to a major overhaul of its security system and adopted a comprehensive Army "biosurety program" in 2003 that included closer tracking of inventories of various germs.
Employees with access to the "hot suites," which are designed to contain anthrax and other pathogens during experiments, must now submit to regular medical, mental health and behavior screening, including monitoring of their use of prescription drugs.
"The safety of the USAMRIID staff and the security of the biological agents on which it works," spokeswoman Caree Vander-Linden said, "have always been top priority, even before the events of 2001."
(McClatchy collaborated with the investigative newsroom ProPublica and PBS's "Frontline" on its inquiry into the FBI's case against the anthrax killer. Gordon works for McClatchy. Engelberg works for ProPublica.)

Vaccine Safety in the News

From the Irish Herald:

We need a jab inquiry

The link between the Pandemrix swine flu vaccination and narcolepsy in at least 16 children has to be scrutinised.

Manufacturers GlaxoSmithKline were indemnified by the State from any liability for side effects as the vaccine was rushed through. We need a full explanation from the Irish Medicines Board about how this vaccine was researched and tested.

From The Australian:

CSL slow to reveal flu jab reactions

AUSTRALIA'S drug regulator will demand an explanation from drug-maker CSL after it emerged the company knew two years ago about research suggesting a sharp rise in fevers linked to its seasonal flu vaccine, but omitted this from information given to doctors.

As health authorities noticed a number of serious reactions to the vaccine early last year, the legally required product information sheets continued to rely on figures from 2005. These showed 22.5 per cent of children under three experienced a fever afterwards, dropping to 15.6 per cent among three- to nine-year-olds.

The same study that produced the 2005 figures contained updated figures for 2006 that showed the rate of fever had nearly doubled, to 39.5 per cent for children aged six months to three years and to 27 per cent for older children.

Both sets of results were published in 2009, but CSL has still not included the more alarming set of figures in the product information...

From The Australian:

Dark Specks in Flu Vaccine 'No Risk'

DARK specks floating in vials of swine flu vaccine posed no safety hazard, CSL has concluded after an investigation sought by the US Food and Drug Administration.

CSL was aware a month before it launched its pandemic vaccine in Australia in September 2009 that "foreign particles" had been found in samples for the US market, the FDA reveals in its 2010 audit of CSL's Melbourne laboratory.  [The most interesting thing about this short articles is that it fails to tell us what those nasty particles are, exactly.  Stopper material?  Aluminum?  Mercury?  Fungi?  How does the consumer know these particulates are safe when injected into our bodies?--Nass]

New adjuvants on horizon for influenza vaccines/ IDSA Annual Mtg

From the Infectious Diseases Society of America annual meeting comes this [WHO] discussion of how novel adjuvants affect the immune response, and how we can expect to see more of these adjuvants added to vaccines in the US:

... Martin Friede, PhD, who heads the Technology Transfer Team within the Department on Innovation, Information, Evidence and Research at the World Health Organization in Geneva, Switzerland, spoke about influenza vaccine adjuvants.
Adjuvants are added to vaccines to improve the immune response. They are known to increase antibody titers; reduce antigen dose (dose sparing for a pandemic); reduce the number of doses needed because they provide more rapid protection; enable immunization in patients with weakened immune systems; provide appropriate bias; and induce cell-mediated immunity, according to Friede.
“They are a critical enabling component for subunit/recombinant vaccines,” he said.
Adjuvants currently approved for global use include aluminum (alum); MF59 (squalene emulsion); AS03 (squalene/tocopherol emulsion); AF3 (squalene emulsion; Virosomes (liposomes)); and polyoxidonium (poly-electrolyte))...

Friede said alum adjuvants are widely used in pediatric vaccines — including DTP, Hepatitis B virus and pneumococcal vaccines — because they enhance titers and they have a long record of safety.
The drawback with alum adjuvants is that they are not really suitable for yearly administration because the adjuvant effect is dependent on many factors, according to Friede. He added that there are challenges that are specific for influenza, including that the antigens are variable and that the benefit for influenza vaccines is not convincing.
“Each year, the influenza antigen with aluminum changes and it is very different to make it consistent,” Friede said.
Despite its limitations, there are several influenza vaccines with alum — whole killed virion vaccines and split vaccines — that are approved for use around the world but not in the United States, according to Friede.
Oil-in-water emulsions are simply droplets of oil in water (~100 nm), the most common of which are squalene & tocopherol and tween & lecithin.
The MF59 adjuvant (Novartis) is made from squalene in water with Tween + Span and has been used in influenza vaccines in European countries since 1996. The push toward development of the MF59 adjuvant began with the last emergence of H5N1 because it required an enormously large dose of antigens needed to get an immune response.
“However, the moment you add oil and water, the immune results were enhanced enormously,” Friede said.
In 2009, when MF59 was incorporated into the 2009 H1N1 pandemic vaccine, it increased global vaccine production capacity to more than 200 million doses distributed for all ages.

The caveat is that there is an increase in local reactogenicity, according to Friede.  (And what about systemic reactogenicity?--Nass)

“You cannot have an omelet without breaking the eggs,” Friede said. “The influenza vaccine with this adjuvant often results in some local site reactions and some redness, but it’s nothing serious...”

“I would say to stay tuned because you may have an influenza vaccine with this adjuvant available in your country soon,” Fried said.

Anthrax Whodunit/ Frederick News Post

Barry Kissin's Opinion piece at the Frederick News-Post

Back on Aug. 29, 2008, The FNP published a column by Katherine Heerbrandt titled "If not Ivins ..." Heerbrandt began with the viewpoint of Norm Covert, a well-known former Fort Detrick public affairs officer: "The anthrax in the mailings, he says, was 'highly bred, weapons-grade ... with a silica coating and a slight electrical charge so that each particle repelled the other ... each particle no more than five microns.' Ivins had neither the expertise nor the equipment to create such a sophisticated form of anthrax ..."

Heerbrandt continued: "Since Nixon terminated the offensive weapons program at Detrick in 1969, there has been only one corporation in our country that operates laboratories where anthrax is weaponized: Battelle Memorial Laboratories, the corporation that does the bio-lab work for the [intelligence agencies] ...
"How do Americans even begin to confront the reality that the only bio-attack in our history came from an American military/intelligence lab?"
On Oct. 10, The New York Times ran a front-page story that contained the following statement: "If Dr. Ivins did not make the powder, one conceivable source might be classified government research on anthrax, carried out for years by the military and the Central Intelligence Agency." Looks like The New York Times is catching up to The Frederick News-Post.
An unavoidably critical piece of evidence has come to light. Scientists have discovered in among the 9,600 pages of documents provided by the FBI to the National Academy of Sciences in 2009 a chart revealing substantial levels of silicon and tin in the attack anthrax as measured in an FBI lab. These levels establish the presence in the attack anthrax of a very advanced weaponizing technology.
The best-selling book "Germs," published in 2002, exposed the existence of up-until-then secret anthrax weaponization projects being managed and operated by Battelle for the CIA and the Defense Intelligence Agency. The very advanced technology that went into the attack anthrax must have been developed in one of those projects.
But specifically whodunit? Mainstream authorities are realizing what Heerbrandt wrote about three years ago. Alice P. Gast, president of Lehigh University and the chairwoman of the National Academy of Sciences panel that reviewed the FBI's science in Amerithrax, was cited by The New York Times thusly: "Dr. Gast, the head of the NAS panel, noted that her group strongly recommended that future investigations of the attacks examine the government's classified work on anthrax."
Future investigations? According to a recent McClatchy Newspapers report, senior Republican Sen. Charles Grassley who has "been skeptical of the case against [Ivins] said adamant opposition from the FBI and Justice Department is likely to block further inquiry into the case."
The FBI and Justice Department have been caught not only peddling a bogus case against Ivins, but also covering up evidence of the anthrax letters' connections to "the government's classified work on anthrax." And all it's going to take to block further inquiry is their "adamant opposition"?
Grassley, certainly no rabble-rouser, also just said, "it would take a powerful grass-roots movement ... to reopen the ... investigation." Frederick is the most natural site for the birth of such a movement.

barrykissin@gmail.com

New questions about FBI anthrax inquiry deserve scrutiny/ Washington Post Editorial

The Washington Post calls for Congress to perform a definitive investigation of the anthrax letters attacks, adding to the impact of the NY Times' editorial asking for the same 3 days earlier:

BRUCE E. IVINS has been dead for three years, but questions still abound about whether he carried out the 2001 anthrax attacks that killed five people and seriously sickened 17 others.

The FBI compiled what appeared to be an overwhelming case against the former microbiologist at Maryland’s Fort Detrick. In the weeks before anthrax-laced letters were mailed, FBI affidavits claimed, Mr. Ivins stayed late nights and weekends at the Army lab that allowed him to work undetected while cultivating the deadly spores. And the FBI provided a possible motive: An anthrax vaccine program Mr. Ivins was working on had run into trouble; an attack could give the project a boost.

But the coup de grace, according to the bureau, was provided by a cutting-edge genetic test of the anthrax spores that linked Mr. Ivins to the attack. Mr. Ivins took his own life in 2008 just as the Justice Department was preparing to charge him.

This scientific evidence came under fire in February when the National Academy of Sciences, which was commissioned by the FBI to review the case, reported that the bureau had not performed enough tests or been precise enough to conclude definitively that Mr. Ivins was the lone culprit.

Now three independent scientists have teamed up to publish a paper in the Journal of Bioterrorism and Biodefense that points to other alleged failings in the FBI’s testing procedures. Also this month, a joint investigation by PBS’s “Frontline” newsmagazine, the ProPublica online newsroom and McClatchy Newspapers raised additional questions about the accuracy of the FBI investigation. For example, the journalists revealed that Mr. Ivins handed over to investigators lab flasks that contained telltale markers found in the anthrax used in the attacks. This revelation appears to contradict FBI assertions that Mr. Ivins withheld or manipulated evidence.

Doubts about the investigation were bound to linger since Mr. Ivins killed himself before he could be tried. But the uncertainty is unacceptable. Congress should convene a panel of independent law enforcement specialists and scientists to pore over the evidence collected in the course of the FBI investigation — including classified information that was withheld from the NAS panel. Such an inquiry should attempt to get to the bottom of the 2001 attacks and assess the nation’s ability to prevent a similar attack.

Anthrax countermeasures better than in 2001, but work remains/ CIDRAP

 What does $60 billion buy in terms of enhanced security?  From CIDRAP we get a detailed look at what our government's bioterrorism establishment has been shopping for:

If someone tried to kill Americans with Bacillus anthracis spores today, the nation would have a better medical tool chest for treating the sick and those potentially exposed than it had 10 years ago, when the anthrax letter attacks killed five people, but anthrax defenses are still a work in progress.

In the event of an anthrax attack, federal response plans call for treating those at risk with a 60-day regimen of antibiotics, and also for offering three doses of anthrax vaccine for longer-term protection against the risk of late-germinating B anthracis spores.

The government has enough doses of antibiotics in its civilian stockpile to treat 60 million people for the recommended 60 days...  US Department of Health and Human Services (HHS) officials won't disclose the amounts of materials in the Strategic National Stockpile (SNS), citing national security concerns.

The SNS also contains enough doses of anthrax vaccine—the same one that was in use in 2001—to protect a few million people...  Meanwhile, several companies are working on second-generation vaccines with the aim of providing protection with fewer doses at less cost, but their availability is still several years away.

The government also has something it didn't have 10 years ago: a supply of antitoxins—anthrax immune globulin (Cangene's AIG, serum extracted from vaccinated servicmembers, at $14,000/dose) and other antibody products (Human Genome Science's monoclonal antibody, at $8,000/dose)—that could be used to treat people with anthrax infections potentially too far advanced for successful antibiotic therapy. None of these have yet been approved by the Food and Drug Administration (FDA), but they can be used under emergency authorizations if needed, federal officials say. One of them was used in a man who was treated in Minnesota for inhalational anthrax in August....

Great.  So we are "ready" for anthrax.  Except, if we are well prepared for anthrax, any serious enemy would pick some other microorganism.  Smallpox, anyone?  Plague?  Tularemia?  Ebola?  How about a newly synthesized bug?

If the US government really wanted to protect us, instead of wasting our childrens' tax dollars on pet pork, it would not have walked out of negotiations to strengthen the Biological Weapons Convention.  It would have cooperated with nearly the entire world to enact provisions in this treaty for verification of compliance, including inspections and sanctions.  But this logical and relatively cheap approach to reducing the threat from state actors has been unpopular in US government circles.

OTOH, can we afford to keep spending $60 billion every few years for a piecemeal, very limited response to the BW threat?  Our current approach offers no meaningful protection against an apparition that, given the technology, can take millions of forms.

Who Mailed the Anthrax Letters?/ NY Times Editorial

Today's NY Times wants to know if the FBI's evidence -- linking Bruce Ivins to the anthrax letters -- really holds up.  Frontline/ProPublica/McClatchy last week informed us, after reviewing thousands of FBI documents obtained through FOIA, that the FBI misled us.  Ivins' late-night hours at the lab in September-October 2001 were not really that different from usual.  Furthermore, Ivins had submitted additional anthrax samples to the FBI, undercutting the FBI claim he failed to cooperate with a sample request in order to hide his involvement in the case.

An article by Martin Hugh-Jones et al. points out that there was too much silicon and tin in the second batch of anthrax to be a contaminant.  Instead it suggested special processing.  Anthrax with these additives was never found in the labs at Fort Detrick, where Ivins worked.  Had the anthrax been grown there, some of these contaminants would have been left behind, and would have been discovered by environmental sampling.  Failing to find them exonerates Ivins, and Fort Detrick, from involvement in preparing the letter spores.

The National Academies panel found the FBI failed to demonstrate Ivins was the perpetrator, and also found that the letters' anthrax was not necessarily grown from Ivins' seed spores.  Ivins' RMR1029 spore preparation had been shared with other labs, and any of those labs (wittingly or unwittingly) might have supplied the seed spores for the letters.  If the FBI misled the public on the "morphotypes" it found in the many anthrax samples tested, the seed spores could have come from other, additional sources.

There was a strong sense of relief when the federal government concluded that a lone psychologically troubled government scientist mailed anthrax-laced letters in 2001, killing five people and terrorizing the nation. Now its evidence is looking increasingly shaky.

Dr. Bruce Ivins, an Army biodefense expert at Fort Detrick in Maryland, committed suicide in 2008 before the case against him could be tested in court. Independent inquiries this year have raised questions both about the genetic analyses that traced the anthrax to Dr. Ivins’s laboratory and a web of circumstantial evidence. There needs to be a new independent evaluation of the findings.

The government’s scientific case has been weakening for months. In February, the National Academy of Sciences warned that the genetic analysis “did not definitively demonstrate” that the mailed anthrax was derived from spores grown in Dr. Ivins’s laboratory. Last week, The Times reported that one of the leading anthrax authorities and two colleagues believe that distinctive chemicals in the mailed anthrax suggest it was produced by sophisticated manufacturing, which the scientists deemed far beyond Dr. Ivins’s capabilities. Although some experts think the chemicals might be meaningless contaminants, the chief of the academy panel and the leader of a pending Government Accountability Office review think the group’s assertions in a future paper need to be addressed.

As for the circumstantial evidence, an investigation by PBS Frontline, assisted by ProPublica and the McClatchy newspapers, cast doubt on two elements that prosecutors had declared important. A contention that Dr. Ivins worked extraordinarily long hours alone at night in his laboratory just before the mailings looked less suspicious after the journalists found that he regularly worked late hours in other labs and offices. And a contention that Dr. Ivins tried to mislead investigators by submitting an anthrax sample free of genetic markers looked questionable after the journalists found that he had submitted other samples that contained the markers.

Federal investigators insist that there is a vast amount of evidence supporting their conclusion of Dr. Ivins’s guilt. The Government Accountability Office needs to dig deeply into classified materials to judge how well the evidence holds up. Otherwise, Congress ought to commission an independent assessment to be sure there are no culprits still at large. 

Previous NY Times editorials here and here got down in the weeds, pointing out big problems with the FBI's case.   The Times editorial brings to mind the critical role the anthrax letters played in recent American history:

• building the case for war in Iraq, despite Saddam Hussein being an enemy of al Qaeda
• helping pass the Patriotic Act 
• helping to justify a national security state 
• justifying 60 billion federal dollars for bioterrorism readiness since 2001, much of which has been wasted (and here is one recent example)
• relicensing the anthrax vaccine manufacturer,  renewing the military anthrax vaccine program, and leading to the purchase of over 2 billion dollars' worth of anthrax vaccine

This is why their true perpetrator(s) needs to be identified and held accountable.

First, airplanes were used as missiles.  The public stopped flying. Then, anthrax-laden letters, which announced what they contained and how to protect against it ("Take penacilin now") sowed fear of contagion through the mail.

That did it.  The United States changed course.  There were a few big winners, but most of us became losers.  We have to find out why.

Despite evidence of FBI bungling, new probe into anthrax killings unlikely/ ProPublica

From Pro Publica:

A senior Republican senator says it would take a powerful grassroots movement or startling new evidence to reopen the Justice Department's investigation that branded a now-deceased Army researcher as the anthrax mailer who killed five people a decade ago.

Iowa Sen. Charles Grassley, the ranking Republican on the Senate Judiciary Committee, and others on Capitol Hill who've been skeptical of the case against the late Bruce Ivins said adamant opposition from the FBI and Justice Department is likely to block further inquiry into the case.

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The Series

Part 1: New Evidence Adds Doubt to FBI’s Case Against Anthrax Suspect

Part 2: Did Bruce Ivins Hide Attack Anthrax From the FBI?

Part 3: Was FBI's Science Good Enough to ID Anthrax Killer?

Video: The Anthrax Files

Interactive: Read and annotate the case documents

Editor's Note: About the Case of the Anthrax Letters

Even if he were the committee chairman, Grassley said, "I would question my capability of raising enough heat (to reopen the case) when you're up against the FBI. And I've been up against the FBI."...

 Rep. Rush Holt, D-N.J., who has criticized the FBI investigation as "botched" and from whose district the deadly letters were mailed, said he may try for a third time to win support for legislation creating a special commission to investigate the attacks.

"There are so many reasons to want to get to the bottom of it," Holt said in an interview. "I hate to think of what lines of investigation have been shut off.  "Nearly all of the evidence was circumstantial, however, and PBS' Frontline, McClatchy and ProPublica, in a one-hour documentary and a three-part newspaper series, disclosed evidence challenging prosecutors' assertions...

Among the evidence the three news organizations scrutinized:

• FBI claims that Ivins worked unusually late hours in a "hot suite," a secure bio-containment lab at Ft. Detrick, in the weeks before the letter attacks. Records show that Ivins had worked similar evening hours in other USAMRIID facilities in the preceding months.
• Assertions that Ivins tried to mislead investigators in April 2002, by manipulating anthrax samples from a laboratory flask he submitted for FBI testing. At issue was whether Ivins was trying to keep investigators from discovering that spores in the flask contained the same genetic variants as those in the anthrax contained in the letters. But while the April samples tested negative for the variants, Ivins gave three other samples to the FBI or fellow researchers between 2002 and 2004 and, ultimately, the bureau recorded positive results in tests of all three, FBI and Army records show.
• Claims that Ivins was motivated to create fear about anthrax because the government's anthrax vaccine program was under heavy fire. The existing program was under fire, and Ivins helped to address problems, but his job was to develop a second generation vaccine that at the time had full funding.
• Assertions that science showed that Ivins' flask was "effectively the murder weapon." A panel of the National Academy of Sciences and two scientists who worked on the FBI investigation described holes in that and other laboratory conclusions...
• Holt and Rep. Roscoe Bartlett, R-Md., whose district includes Ft. Detrick, tried to push through an amendment to a spending bill last year requiring the inspector general for the intelligence community to investigate whether all relevant foreign intelligence had been passed to FBI investigators. The measure was torpedoed when the Office of Management and Budget objected, calling it "duplicative" and expressing concern about Congress directing an inspector general "to replicate a criminal investigation."
  Last May, McClatchy disclosed that the FBI had never explained tests showing the presence of unusually high levels of silicon and tin in the letters sent to the New York Post and to Democratic Sen. Patrick Leahy of Vermont. That renewed suspicions -- denied by the FBI -- that the perpetrator used a chemical additive to keep the spores from clumping so they'd be more easily inhaled.
  Another issue is the FBI's method for collecting anthrax samples from U.S. and foreign labs to narrow the suspect list. Because the samples were subpoenaed and couldn't be seized for multiple reasons, critics have said their submission amounted to an honor system in which the killer would have no incentive to participate.
  Further, a still-confidential 2002 review of security at USAMRIID by a seven-member team from the Sandia National Laboratories found that "the culture at USAMRIID does not reflect the same indisputable commitment to security as it does to research."
  The "diversion of small quantities" of deadly pathogens can be significant, noted the report, a copy of which was obtained by McClatchy, ProPublica and Frontline. That's presumably because they can be used as seed material to grow large quantities of germs for an attack. The problem is heightened, it said, because germs "cannot be reliably detected," underscoring the importance of an alert and cooperative research staff.