This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.
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 www.scientiapress.com.
THE FBI’S ANTHRAX LETTERS INVESTIGATION: POINTS TO CONSIDER
MERYL NASS, MD
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?
SOME FAILURES IN THE FBI’S 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.
MEANS, MOTIVE AND OPPORTUNITY
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.
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.
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...”
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.
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.
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..."
... 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.
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?
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?
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.
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.”
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.
PROGRAM:
1:00 pm: Registration, coffee and tea 1:30 pm: Introduction: Peter Katona, UCLA, Master of Ceremonies 1:50 pm: Panel I: The Investigation
Leonard Cole, Rutgers University, author, The Anthrax Letters
5:00 pm: End
SPEAKERS … 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.
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
EDITORIALS
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.4
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
year.
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.10 Central to any system of vaccine safety monitoring are issues of
governance; specifically, transparency in decision making. Other
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
Australia.
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.
"Similar to previous findings conducted in hospital healthcare workers and nurses, we confirmed that the willingness of community nurses to accept influenza A (H1N1) vaccination is low. Future studies that evaluate interventions to address nurses' specific concerns or interventions that aim to raise the awareness among nurses on the importance of influenza A (H1N1) vaccination to protect vulnerable patient populations is needed."
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.
PROGRAM:
1:00 pm: Registration, coffee and tea
1:30 pm: Welcome: Peter Katona, UCLA, Master of Ceremonies
"A computer failure caused a break in communication with 50 nuclear missiles at Warren Air Force Base in Wyoming during the weekend, military officials said Tuesday." The military did not see fit to inform the President until today, 3 days after the incident. You didn't really think Obama was running this show, did you?
How the newly released US military files reveal an instruction to ignore detainee abuse by Iraqi authorities; what that meant on the ground; and just how far up the chain of command the order went, from the Guardian.
The Health Department has exposed drug company "inconsistencies" but ruled them out as the cause of fits in children given a flu vaccine.
CSL's world-first combination of seasonal and swine flu strains was suspended for the under-fives in April, after it triggered febrile convulsions in young children at nine times the usual rate.
The Health Department's drugs regulator, the Therapeutic Goods Administration, yesterday circulated the latest findings of a six-month investigation into the vaccine scare, pointing to an unusually high level of protein in CSL's Fluvax vaccine.
The TGA revealed that its audits of CSL's laboratory in Melbourne in May and June had observed "a number of inconsistencies with good manufacturing practices", to be followed up in a third audit next month.
"The TGA . . . was satisfied that the observations did not present an increased risk to the quality, safety or efficacy of CSL's vaccine products. [Seizures are not a safety problem?!!]
The TGA said an investigation led by Nobel laureate Peter Doherty had not found a conclusive cause of the convulsions.
But the "current working hypothesis" was that the strain of swine flu used in this year's seasonal flu vaccine appeared to contain a higher than usual level of a protein called neuraminidase.
"Excess neuraminidase enzyme activity may be pyrogenic (producing fever) and may thus be contributing to the increase in febrile reactions in young children receiving the vaccine for the first time," the TGA said.
The TGA also revealed it would continue its suspension of Fluvax for healthy under-fives next year.
"Despite extensive analysis, the biological basis for the excess cases of fever and febrile convulsions remains unclear, and it is therefore important to effectively mitigate the risks by limiting exposure to those at greatest risk," it says.
Liberal senator Concetta Fierravanti-Wells yesterday called on the TGA to release details of audits that found deficiencies in 136 of the 139 laboratories manufacturing medicines in Australia.
"We must have more transparency," Senator Concetta Fierravanti-Wells said.
GlaxoSmithKline Plc agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs.
The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet.
“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,” PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.
“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.
The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.
“We did not uncover any evidence that patients were harmed from these adulterated batches,” Ortiz said today. “It is critical we keep pressure on companies to follow FDA standards and play by the rules.”
[UK Deputy Prime Minister Nick Clegg was] asked if there should be an inquiry into the role of British troops, [and] said: "I think anything that suggests that basic rules of war, conflict and engagement have been broken or that torture has been in any way condoned are extremely serious and need to be looked at. "People will want to hear what the answer is to what are very, very serious allegations of a nature which I think everybody will find quite shocking."
A Channel 4 Dispatches programme on Monday night is expected to add further details based on the logs of alleged abuse directly by coalition forces. Only two cases of alleged involvement of British troops have so far been mentioned.
Within the huge leaked archive is contained a batch of secret field reports from the town of Samarra. They corroborate previous allegations that the US military turned over many prisoners to the Wolf Brigade, the feared 2nd battalion of the interior ministry's special commandos.
In Samarra, the series of log entries in 2004 and 2005 describe repeated raids by US infantry, who then handed their captives over to the Wolf Brigade for "further questioning". Typical entries read: "All 5 detainees were turned over to Ministry of Interior for further questioning" (from 29 November 2004) and "The detainee was then turned over to the 2nd Ministry of Interior Commando Battalion for further questioning" (30 November 2004).
The field reports chime with allegations made by New York Times writer Peter Maass, who was in Samarra at the time. He told Guardian Films : "US soldiers, US advisers, were standing aside and doing nothing," while members of the Wolf Brigade beat and tortured prisoners. The interior ministry commandos took over the public library in Samarra, and turned it into a detention centre, he said. An interview conducted by Maass in 2005 at the improvised prison, accompanied by the Wolf Brigade's US military adviser, Col James Steele, had been interrupted by the terrified screams of a prisoner outside, he said. Steele was reportedly previously employed as an adviser to help crush an insurgency in El Salvador.
The Wolf Brigade was created and supported by the US in an attempt to re-employ elements of Saddam Hussein's Republican Guard, this time to terrorise insurgents. Members typically wore red berets, sunglasses and balaclavas, and drove out on raids in convoys of Toyota Landcruisers. They were accused by Iraqis of beating prisoners, torturing them with electric drills and sometimes executing suspects. The then interior minister in charge of them was alleged to have been a former member of the Shia Badr militia.
...Lawyers said the reports may embroil British as well as US forces in an alleged culture of abuse and extrajudicial killings...
... An analysis of official death certificates on file at the State Department of Public Health reveals that more than 1,000 California veterans under 35 died between 2005 and 2008. That figure is three times higher than the number of California service members who were killed in the Iraq and Afghanistan conflicts over the same period. The Pentagon and Department of Veterans Affairs said they do not count the number of veterans who have died after leaving the military.
... The data show that veterans of Iraq and Afghanistan were two and a half times as likely to commit suicide as Californians of the same age with no military service. They were twice as likely to die in a vehicle accident and five and a half times as likely to die in a motorcycle accident.
"These numbers are truly alarming and should wake up the whole country," said United States Representative Bob Filner, Democrat of San Diego, who is the chairman of the House Veterans' Affairs Committee. "They show a failure of our policy..."
LONDON - The United Nations has called on United States President Barack Obama to order a full investigation of the involvement of US forces in human rights abuses in Iraq, after the massive leak of military documents by the WikiLeaks website.
The intelligence logs show how the US authorities failed to investigate hundreds of reports of abuse, torture, rape and murder by Iraqi police and soldiers whose conduct appears to be systematic and generally unpunished.
Speaking on the BBC's Today programme, the UN special rapporteur on torture Manfred Nowak, who has spent years investigating allegations of US participation in extraordinary rendition and the abuse of detainees held by coalition forces, said the Obama administration had a legal and moral obligation to fully investigate credible claims of US forces' complicity in torture.
A failure to investigate, Mr Nowak suggested, would be a failure of the Obama government to recognise its obligations under international law.
UN human rights agreements oblige states to criminalise all forms of torture, whether directly or indirectly, and to investigate any allegations of abuse.
The principle of "non-refoulement" also prohibited states from transferring detainees to other countries that could pose a risk to their personal safety.
The documents, which cover the period in Iraq from 2004, have prompted claims that this principle has not been observed. The files contain evidence that US forces were ordered to turn a blind eye to abuses committed by the Iraqi authorities...
The call, by the UN's chief investigator on torture, Manfred Nowak, came as Phil Shiner, human rights specialist at Public Interest Lawyers in the UK, warned that some of the deaths documented in the Iraq war logs could have involved British forces and would be pursued through the UK courts. He demanded a public inquiry into allegations that British troops were responsible for civilian deaths during the conflict...
The logs paint a disturbing picture of the relationship between US and Iraqi forces. Nowak said that UN human rights agreements obliged states to criminalise every form of torture, whether directly or indirectly, and to investigate any allegations of abuse... The files contain evidence that US forces were ordered to turn a blind eye to abuses committed by the Iraqi authorities.
Numerous reports of detainee abuse, often supported by medical evidence, describe prisoners shackled, blindfolded and hung by wrists or ankles and subjected to whipping, punching, kicking or electric shocks. Six reports end with a detainee's apparent death...
[Nowak] noted that neither the US nor Iraq had ratified the international criminal convention that would see officials from either country brought before the international courts for war crimes...
... the logs reveal that the coalition has a formal policy of ignoring such allegations. They record "no investigation is necessary" and simply pass reports to the same Iraqi units implicated in the violence. By contrast all allegations involving coalition forces are subject to formal inquiries. Some cases of alleged abuse by UK and US troops are detailed in the logs...
On 3 December 2008 another detainee, said by police to have died of "bad kidneys", was found to have "evidence of some type of unknown surgical procedure on [his] abdomen"...
Assange highlighted how the reports documented 109,000 deaths – including 66,000 civilians, of which 15,000 were previously undocumented. "That tremendous scale should not make us blind to the small human scale in this material. It is the deaths of one and two people per event that killed the overwhelming number of people in Iraq."
Why are we still turning Afghanistan into chopped liver? Why are we spending our children's blood, money we don't have, and our reputation on Hamid Karzai and his country, which has been the destroyer of empires and may yet destroy ours? What precisely is the treasure our leaders are seeking? I feel like the USA has gone down Alice's rabbit hole. We citizens don't know what the rules are, nor what the endgame is. And our pawn Karzai collects bags of cash from us and our sworn enemy. You explain it to me.
Kabul, Afghanistan (CNN) -- President Hamid Karzai of Afghanistan acknowledged Monday that he has received cash payments from Iran.
The president said Iran has "asked for good relations in return and for lots of other things in return" for the cash. "And we've also asked for lots of things in return in this relationship, so it's a relationship between neighbors." He also said the cash was given "to people outside."
His comments followed a report in The New York Times that Iranian officials gave Karzai bags of cash.
Karzai equated the cash from Iran with assistance the United States has provided to Afghanistan. He also said the United States is and has been aware of Iran's help.
"We are grateful to Iran for the help that they are giving and to those receiving that help under my instruction," he said.
"The cash payments are done by various friendly countries to help the president's office and to help, dispense assistance in various ways to the employees around here, to people outside, and this is transparent and this is something that I have discussed," Karzai told CNN.
"Even when we were at Camp David with President Bush, this is nothing hidden."
The government needs to know the true cost of the products it's purchasing to avoid getting fleeced by unscrupulous suppliers
A soldier being inoculated for anthrax in 2000.
The Pentagon has paid the manufacturer of BioThrax $1.3bn, for a vaccine that an independent report calculates cost only $250m to produce. Photograph: AP/Dave BowmanAn anthrax vaccine of contested quality has paid out over $1bn in profit to a small company in Maryland, despite the fact that the company neither invented the product nor built the production facilities. A new report by Scott Lilly, my colleague at the Centre for American Progress in Washington, has the details: Emergent BioSolutions has billed the Pentagon $1.3bn for BioThrax, which he calculates cost the company roughly just $250m to manufacture. Lilly comments:
"It is hard to imagine that any attempt to reduce federal outlays and shrink the size of the budget deficit will be credible if it does not address the issue of government contracts that pay extraordinary profit margins."
... BioThrax is considered a "commercial item" – despite the fact that consumers cannot buy it on the open market. Originally developed by military scientists at Fort Detrick, Maryland, in the 1960s, the state of Michigan public health service obtained a licence to produce the vaccine in 1970. At the time, BioThrax was used to help protect mill workers in the textile industry who processed animal hair contaminated with naturally-occurring anthrax.
In 1998, the state of Michigan sold off the facility for an effective cash price of $2.25m – including 28 buildings containing 250,000 square feet of floor space; 59 acres of land and the government licence to manufacture BioThrax.
Today, it has become very clear that BioThrax is both old and very inadequate. A 2002 review of the vaccine by the Institute of Medicine concluded that BioThrax caused swollen arms and muscles, as well as joint pain. According to some campaigners, it may even have resulted in the death of some individuals.
The new owners, which are now a publicly-listed company named Emergent BioSolutions, have three in-house and 24 contract lobbyists. (Lilly explains that, to put Emergent's lobbying in perspective, one might compare it with Merck, one of the most heavily represented companies in Washington, with close to 40 registered lobbyists. To have the same ratio of lobbyists to revenues as Emergent, Merck would have to hire more than 4,000 additional lobbyists.)
Tony Fauci (head of NIH's NIAID), alsong with David Morens and Jeffrey Taubenberger, both renowned flu experts, have run the numbers and concluded that a majority of Americans are already immune to swine flu, either from last year's vaccination (62 million) or a prior exposure. Most of those exposed never got sick.
In a paper titled, "The 2009 H1N1 Pandemic Influenza Virus: What Next?" they note that 19% of Americans (60 million people) had immunity even before the swine flu outbreak was identified in Mexico in March 2009, based on seroprevalence data. They estimate another 20% of Americans (61 million people) were naturally infected since March 2009 with the swine flu virus.
The authors write,
Given the relatively low number of infections estimated so far for persons older than 50 years and the possibility that standard measurements may underestimate immunity, there may be a higher degree of population protection than predicted. [i.e., greater than 59%--Nass]
... we do not know the extent to which preexisting cross-reactive antibodies can prevent infection or disease. It is noteworthy that in past pandemics (e.g., the 1957-1958 pandemic), significant numbers of persons with probable prior exposures but without detectable cross-reactive antibodies seem nevertheless to have been protected, as were some people with low-level cross-reactive antibodies against distantly related viruses
Which begs several questions: If a majority of us are already immune to H1N1 (swine) flu, how many of us are immune to the other components of this year's flu vaccine? If those vaccinated last year are considered still immune to swine flu, aren't those people vaccinated last year with the seasonal flu vaccine still immune, in general, to the other components of this year's flu vaccine?
Since H1N1 is not a highly virulent virus, and there remain significant questions about the safety of the 2010 vaccine, especially in children, why are we pushing universal vaccination against it?
Why not do serologic testing and only offer vaccine to the minority of Americans who remain susceptible?
And how can you possibly justify firing workers who refuse vaccination when they may already be immune to what the vaccine contains? I'd love to see that litigated in a courtroom, especially for healthcare workers who are likely to have much higher levels of immunity that the average person, since they are in contact with those who are sick!
Ambulance chiefs face renewed pressure to explain the loss of a key medical record relating to the death of Dr David Kelly after the investigating police force said it had no record of ever having received the document.
Bosses at South Central Ambulance NHS Trust were criticised last month when The Mail on Sunday revealed they could not find the patient report form (PRF) completed by paramedic Vanessa Hunt, who attended the scene of the former weapons inspector’s death in 2003...
Dr Michael Powers QC, who is leading a group of doctors campaigning for an inquest into Dr Kelly’s death, accused the Ambulance Trust of trying to shift the blame.
‘The document is the closest thing to a full record of what the ambulance team at the scene saw and noted down. I would have expected such a form to have been filled out and to have been kept, particularly given national and international interest in the case.’
At the time of the death, Ms Hunt and her colleague Dave Bartlett, who also attended the scene in woods near Dr Kelly’s home, worked for Oxfordshire Ambulance Trust.
Mr Bartlett’s claim in The Mail on Sunday last month that Dr Kelly’s body had been moved added to the increasing demand for an inquest...
Secret files on the death of Dr David Kelly will be handed over to medical experts to see if the suicide verdict can be challenged.
Ministers want independent advice on whether there are any discrepancies or unanswered questions in the post mortem examination report.
Home Office pathologist Nicholas Hunt concluded the weapons inspector died after cutting a small artery in his wrist. But a group of doctors campaigning for an inquest into Dr Kelly’s death claim he would not have lost enough blood to end his life.
Attorney General Dominic Grieve wants to establish whether they have a solid case.
The Mail can reveal the doctors have now begun legal action, calling on Mr Grieve to petition the High Court for an inquest.
... Lord Hutton had instructed the papers should remain secret for 70 years. But Mr Grieve used special powers he holds to take control of the files – which campaigners believe could hold the key to the case...
From: [redacted]
To: [redacted]
Sent: Wednesday, December 12, 2007 12:30 PM To:
Subject: Question about MRIID (UNCLASSIFIED)
Classification: UNCLASSIFIED Caveats: NONE
__(b) (6)_____asked me about something that _(b) (6)_____ told her. There was weaponized anthrax that came to Detrick and then was shipped out and some was missing. I told her I would ask if any situation occurred that led him to say this. I remember the Southern Research issue when they shipped anthrax to California, and it got lost. I think they ended up locating it. (remainder redacted)
People in Australia are waking up to the evidence that in some cases, vaccines cause more harm than good. Furthermore, the longterm sequellae from a seizure are likely to be more serious than from flu. From the Sydney Morning Herald Sept 18:
PUBLIC health experts have called for an independent body to monitor drug safety after it emerged that young children were more likely to end up in hospital because of side effects from a flu vaccine than they were from the disease itself.
The analysis contradicts government safety advice that the harm did not outweigh the risk and raises concerns about the Therapeutic Goods Administration's assessment of the vaccine.
More than 1000 adverse responses in children under five were reported to the TGA by June this year, including nearly 100 instances of febrile convulsions, a seizure which in a small number of cases has been associated with long-term adverse health outcomes.
The side effects were linked to one of the three seasonal flu vaccines, Fluvax and Fluvax junior, from the drug company CSL, but the TGA maintained despite that, that "the overall risk-benefit balance of both products remains positive".
But research published yesterday in the journal Eurosurveillance showed Fluvax might have caused two to three hospital admissions due to seizure for every admission from flu it prevented. The chief executive of the Public Health Association of Australia, Michael Moore, said further examination of risks was needed, at arm's length from the TGA. The government should consider creating an independent centre.
"There is a concern … that the TGA is the body that approves vaccines and is also the body that determines what the risks and benefits are when concerns are raised," he said.
Peter Collignon, an infectious diseases expert at the Australian National University, said the vaccination program in children under five did more harm than good. "The TGA made that decision [about risk-benefit] without any evidence to back it up."
... Professor Bishop (Commonwealth chief medical officer) told the Herald yesterday thatwhile the rate of convulsions linked to Panvax was about four times higher than the usual experience with flu vaccinations, it was not comparable with Fluvax, where the convulsion rate had been 50 times higher...
Dr. Meryl says "DUH?!" Panvax only quadruples seizures in kids, while Fluvax increases seizures by a factor of 50. This is supposed to assuage my concerns about Panvax? Why doesn't the Commonwealth tell the public how many healthy children die or become disabled by influenza each year? For the 4 years prior to 2009-10, less than 100 children died each year from influenza in the US, and most were probably chronically ill to start with. Australia's population is about 1/15th of the US. An extrapolation suggests 4 children die each year from flu in Australia, and probably 2 or 3 are chronically ill. How many seizures is it acceptable to cause to prevent 4 deaths? How many other, unidentified vaccine injuries can be caused as acceptable collateral damage? Where is the risk/ benefit balance?
EUROPE and the US have banned an Australian-made flu vaccine for young children, after a surge in febrile fits in Australian children.
The US Advisory Committee on Immunisation Practices has taken stronger action than Australia's Health Department, by recommending that children younger than nine not be vaccinated with CSL's seasonal flu vaccine.
Europe has followed Australia's decision to suspend the CSL vaccine only for the under-fives...
Australian health authorities suspended the use of CSL's seasonal flu vaccine, Fluvax, for the under-fives in April, after it was found to trigger febrile fits at nine times the normal rate.
WASHINGTON - Federal law enforcement and national security officials are preparing to seek sweeping new regulations for the Internet, arguing that their ability to wiretap criminal and terrorism suspects is "going dark" as people increasingly communicate online instead of by telephone.
Essentially, officials want Congress to require all services that enable communications - including encrypted e-mail transmitters like BlackBerry, social networking Web sites like Facebook and software that allows direct "peer to peer" messaging like Skype - to be technically capable of complying if served with a wiretap order. The mandate would include being able to intercept and unscramble encrypted messages.
The bill, which the Obama administration plans to submit to lawmakers next year, raises fresh questions about how to balance security needs with protecting privacy and fostering innovation. And because security services around the world face the same problem, it could set an example that is copied globally...
Although CDC said it would not support mandatory flu vaccinations for healthcare workers (imagine the lawsuits if this were a federal government mandate), various organizations have recently published policy statements* in favor of such mandatory inoculations for all workers in healthcare facilities.
What is truly strange about this effort is that you cannot find convincing medical studies that show that vaccinating healthcare workers for flu actually decreases cases, on a statistical basis. Sure, patients come down with flu after being admitted to hospital, and one can cite a death here or there. But no one has shown that vaccinating workers leads to healthier patients or fewer deaths, and the lack of convincing evidence undercuts the scientific and legal basis for mandating healthcare worker vaccinations.
Gregory A Poland, MD has authored a large number of papers pushing mandatory flu vaccinations, and has been the prime mover for this initiative since the 1990s. Dr. Greg has been a CDC Advisory Committee on Immunization Practices member, and done vaccine studies for many pharmaceutical firms at Mayo Clinic, where he heads the vaccine research group. He also was hired by the Defense Department in 1999 to go to military bases and promote anthrax vaccinations. After I noted about 20 misstatements in his presentation on anthrax and anthrax vaccine on my website, the talks abruptly ceased.
"In Dr. Poland's war, there are no rules of engagement; anything goes."
And Poland acknowledges the lack of evidence supporting vaccinations in this 2007 piece:
Jacobson RM, Targonski PV, Poland GA. Why is evidence-based medicine so harsh on vaccines? An exploration of the method and its natural biases. Vaccine. 2007 Apr 20;25(16):3165-9.
UPDATE: Here is the abstract for Poland's article:
"Vaccines have been hailed as one of the greatest success stories of public health in the 20th century. The 20th century also produced a call for evidence-based medicine (EBM) with applications inclusive of preventive health. Since then, several major EBM analyses have called into question vaccine practices well-accepted by physicians, public health officials, and even the lay public. For example, while counter to existing studies and policies, EBM analyses have concluded that data are lacking to support influenza vaccination of healthcare workers to prevent flu complications among the elderly. In this review, we examine the criticisms and consider the shortcomings in the field of vaccinology as well as in the methodology of evidence-based medicine."
And here are Dr. Greg's disclosures for another 2007 article:
Gregory A. Poland, MD, is the director of the Vaccine Research Group at Mayo Clinic, Rochester, MN, and has disclosed that he has served as a consultant to
Dynavax,
Novavax,
Merck,
Protein Sciences,
GlaxoSmithKline,
Novartis Vaccines,
CSL Biotherapies, and
Avianax.
Dr. Poland has also disclosed that he has received research grants from Novavax and Merck.
Dr. Poland has also disclosed that he has served as a chair for the novel vaccine DMSB for Merck.
There will always be people who think they know (or are paid to know) what is best for the rest of us, evidence be damned, and will do their best to coerce us to comply. Most of the know-it-alls in this case have been shown to be compromised by their income from the vaccine industry, and it appears their input was critical in creating the swine flu boondoggle last year. Funny how failure doesn't stop them.
* One author reports that he is a consultant for Joint Commission Resources. He and some other authors report various financial relationships with Avianax, BD Diagnostics, Care Fusions, CSL, Cubist, EMD Serono, Emergent BioSolutions, GlaxoSmithKline, Human Genome Sciences, Liquidia Technologies, MedImmune, Merck, Novartis Vaccines and Therapeutics, Novavax, OrthoMcNeil, PaxVax, Pfizer, Rymed Technology, Sage, Sanofi Pasteur, Theraclone Sciences (formally Spaltudaq Corporation), Vaxxinate, and/or Wyeth. This is according to Medscape.
We have not declared war against Pakistan, and Congress has not approved making war in Pakistan. Yet we illegally send drones there to kill, and our CIA runs a mercenary army in Pakistan. The American Rule of Law is what took the biggest hit on 9/11.
Recently there have been criticisms that BARDA has not spent much of the 6 billion dollars set aside for biological and chemical warfare treatments and preventive strategies after 9/11. In fact, a plan was introduced to transfer some of the monies into other programs.
In good bureaucratic fashion, BARDA responded by spending. Emergent BioSolutions, aka Bioport, will be the beneficiary of more largesse from the federal government. BARDA, meanwhile, has demonstrated its commitment to develop a next-generation, recombinant anthrax vaccine despite earlier failures and many millions down the drain in this pursuit during the past ten years.
Like all flu seasons, mortality in the elderly was highest from swine flu during the 2009-10 season
Preexisting antibodies were common in the elderly: present in 88% of those aged 90-99, present in 27% of those aged 79, and present in 4-5% in those younger than 60.
Six studies from Canada consistently found that prior year vaccination in 2008/09 for seasonal influenza was associated with a 1.4- to 2.5-fold increased risk for hospitalization for H1N1 infection, said Naveed Z. Janjua, MD, also from the British Columbia Centre for Disease Control.
"As for the mechanism behind those differences, studies in swine suggest that a vaccine that induces "nonneutralizing or subneutralizing concentrations of antibody can enhance the infection rather than protect from that infection," Dr. Janjua said.
Dr. Skowronski acknowledged the limitations of case–controlled studies. She suggested that the Canadian findings might be more rigorous than similar studies from the United States and Mexico that reached different conclusions on the effect of vaccination for seasonal influenza on H1N1 infection.
Good immunization records and the use of a single brand of vaccine within a geographic region also are factors contributing to the rigor of the Canadian analysis, she pointed out.
The studies were conducted with funding from various Canadian government agencies. None of the presenters disclosed no relevant financial relationships."
After years of questioning the conclusion and methods of an FBI investigation into the 2001 anthrax attacks that killed five people and sickened dozens of others, Rep. Rush Holt (D-Hopewell) announced yesterday that the U.S. Government Accountability Office (GAO) is opening an inquiry into the matter.
Holt, along with a handful of other legislators, had sent a letter to the GAO in May requesting an investigation into the FBI’s handling of the case. The FBI officially closed the case in February after concluding in 2008 that Dr. Bruce Ivins, a former biodefense scientist, was the sole culprit in the attacks.
Ivins, a resident of Frederick, Md., committed suicide shortly before government investigators planned to formally file charges against him.
“In the wake of the bungled FBI investigation, all of us — but especially the families of the victims of the anthrax attacks — deserve credible answers about how the attacks happened and whether the case is really closed,” Holt said in a statement yesterday.
Holt has charged in the past that the FBI investigation failed to address basic questions including Ivins’ motive and his connections with the local area.
Investigators determined that at least one of the letters was sent from a mailbox on Nassau Street in Princeton Borough. The letters were sorted at a postal service facility on Route 130 in Hamilton, where several employees became ill.
“The American people need credible answers to many questions raised by the original attack and the subsequent FBI handling of the case,” Holt said. “I’m pleased the GAO has responded to our request and will look into the scientific methods used by the FBI.”
The GAO’s investigation will look to address a handful of specific questions as requested by Holt.
He asked the agency to identify and judge the quality of the microbial and technical forensics methods employed by the FBI in concluding Ivins was responsible for the attack. He asked what, if any, scientific concerns and uncertainties remain after the closure of the official investigation. Finally, he wanted to determine what agencies are responsible for monitoring high containment laboratories.
However, officials with the GAO, in accepting Holt’s request for an inquiry, admitted that its efforts may be hampered by lack of access to classified material.
“Please know that we may encounter challenges to our access to sensitive and classified information from the FBI and the intelligence agencies,” Ralph Dawn Jr., managing director of congressional relations for the GAO, said in a letter to Holt last month.
In 2008, the FBI commissioned its own inquiry from the National Academy of Sciences (NAS) into the results of its investigation. The results of the NAS report are expected to be released later this year.
Holt has also introduced legislation calling for a formal congressional commission to investigate the attacks. Similar to the 9/11 Commission, the panel would hold hearings and be granted subpoena power.
Officials with the Obama administration earlier this year said the president would veto any such legislation, saying it would be redundant in the wake of the FBI and NAS investigations.
The investigative arm of Congress will take another look at the science the
FBI used to determine who mailed deadly anthrax-laced letters in 2001.
The Government Accountability Office has notified Rep. Rush Holt, a New
Jersey Democrat, that the agency will review the science behind the FBI's
conclusions that Army scientist Bruce Ivins sent the letters that killed
five people.
The letters were mailed from a mailbox in Princeton, N.J., which is in
Holt's district. The congressman has long maintained that the FBI's work on
the case was shoddy and full of holes. The FBI concluded Dr. Ivins was a
disturbed man who sent the letters while his laboratory faced the prospect
of losing support for its anthrax vaccine program.
The National Academy of Sciences is in the midst of a two-year-review of the
scientific work that led the FBI to finger Dr. Ivins after spending years
chasing other suspects. Dr. Ivins took a fatal overdose of pills in 2008 as
a federal grand jury prepared to indict him for the anthrax mailings.
In a letter to Holt, GAO officials said they would conduct their review once
the NAS reaches its conclusions, which is expected later this year.
Despite a recent attempt to paint last year's swine flu pandemic as more serious than thought, based on its higher attack rates and complications in a younger population, a new study using Wisconsin data, reported by Agence France Presse, calls those conclusions into question:
Children, which the 2009 H1N1 pandemic infection appeared to disproportionately affect, were not associated with more hospital admission or pneumonia cases when compared with seasonal H1N1 or H3N2, said the study. Within thirty days of infection, six out of 395 children with the 2009 H1N1 virus, or 1.5 percent, were admitted to hospital, compared to five of 135 with seasonal H1N1 (3.7 percent) and eight of 255 with the H3N2 virus (3.1 percent). For adults six out of 150 with 2009 H1N1 or 4.0 percent went to hospital, compared to 17 out of 377 cases of H3N2, or 4.5 percent. "Our results suggest that the clinical manifestations and risk of hospital admission are similar for 2009 H1N1 and other seasonal influenza A strains," said the study's authors.
"The perceived severity of symptoms and risk of serious outcomes (pneumonia or hospital admission) were not increased," they added.
According to Finland's YLE, The narcolepsy rate appears to be at least ten times normal after swine flu vaccination, and may be higher still given the narrow age range of 5 to 15 years reported from Finland. On average, 3 cases are diagnosed in Finland annually, but 12-14 cases have been detected there with onset between last December and February.
What other neurological (or other types of) disorders might also be occurring as a result of last year's flu vaccines? It is relatively easy to identify increased rates of rare but extremely serious diseases, especially when the rate may have spiked ten-fold. It is much harder to identify increased rates of more common or less severe diseases that may result after vaccinations. What epidemiological efforts are being made to do so?
The Chicken Littles (flu experts) continue to exhort us to not let our guard down despite the overblown fears of swine flu: avian flu "could spark the next global outbreak." Speaking to reporters on the sidelines of a flu conference in Hong Kong, Robert Webster warned against complacency:
We may think we can relax and influenza is no longer a problem. I want to assure you that that is not the case," said Webster, chairman of the virology and molecular biology department at St. Jude Children's Research Hospital in Memphis, Tennessee.
Webster predicted that the next pandemic could be sparked by a virus that spreads from water fowl to pigs and then onto humans — such as the H5N1 strain of bird flu, which has killed 300 people over the past seven years. He noted that after several years of decline, the number of bird flu cases in humans increased in 2009, lifted by an uptick of cases in Egypt.
I am a board-certified internal medicine physician. I have given 6 Congressional testimonies and testified for legislatures in Maine, Massachusetts, Vermont, New Hampshire, Alaska, Colorado and New Brunswick, Canada on bioterrorism, Gulf War syndrome and vaccine safety/vaccine mandates. I have consulted for the World Bank, the Government Accountability Office, the Cuban Ministry of Health and the US Director of National Intelligence regarding the prevention, investigation and mitigation of chemical and biological warfare and pandemics.
I was the first person in the world to investigate an outbreak and prove it was due to biological warfare, publishing the results in 1992. This was the world’s largest anthrax outbreak, which occurred during Rhodesia’s civil war. I was a main author, along with Robert F Kennedy Jr. and the NGO Childrens Health Defense, of a Citizen’s Petition to the FDA regarding the Covid vaccines' authorizations and their single approval, and a letter to the FDA and its vaccine advisory committee regarding the many reasons the vaccines are not suitable for children.
I am also the author of detailed articles regarding the suppression of hydroxychloroquine and ivermectin for treatment of Covid, which have been read by over 50,000 people on my website, and been reprinted on many other sites. I have been interviewed by all major US newspapers, TV networks, and numerous alternative channels.
Meryl and other panelists at Anthrax Letters seminar, Washington, D.C., November 29, 2010
Meryl, enjoying spotting animals in the Thai jungle
Visiting tigers (inside the cages) in Chiang Mai
I think I'm in the wrong cage...
Night shot of a wild elephant
Canoodling at Elephant Nature Camp, Thailand
5 and 7 month olds playing
Mum and her 5 month old infant
Dusky Langur, curious about us humans in his territory
Self-satisfied Dusky Langur, after he relieved himself on me
Rhesus macaque: "I need three hands for this meal"
After swimming with dolphins at Key Largo, they checked me out at the edge of the pool
Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)
Why am I blogging?
Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.
Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.
The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.
Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.
Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.
Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?
So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.
Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.
Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.
Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.
