Tuesday, November 30, 2010


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

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



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

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

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

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

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

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

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

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

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

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

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

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

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

     3d slide – Tylenol poisoning, Merck Manual

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

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

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

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

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


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

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

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

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

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

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

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

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

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


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

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

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

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

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

MICROBIAL FORENSICS and the National Academy of Science panel

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

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

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

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

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

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

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

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

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

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

Tuesday, November 23, 2010

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

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

Friday, November 19, 2010

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

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

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

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

Thursday, November 18, 2010

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

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

Wednesday, November 17, 2010

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

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

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

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

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

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

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

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

Sunday, November 14, 2010

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

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

Wednesday, November 10, 2010

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

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

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

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

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

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

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

The Anthrax Mailings Investigation

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

UC Washington Center, 1608 Rhode Island Ave. NW

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

Please RSVP, acceptances only, to Joseph R. McGhee at the IGCC Washington office:  Phone (202) 974-6295; Fax (202) 974-6299; email: joseph.mcghee@ucdc.edu .  For more on IGCC, see http://www-igcc.ucsd.edu.


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

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

Monday, November 1, 2010

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

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

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

492 MJA• Volume 193 Number 9 • 1 November 2010


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

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

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

For disclosures, footnotes and author information go here.