This year's seasonal flu vaccines

Flu vaccine is being recommended for the entire US population over 6 months of age, starting this year.

The (non-live) vaccines will contain 3 antigens, one of which is the antigen used for swine flu vaccines since late 2009.

In 2009, DHHS Secretary Sibelius issued a Public Readiness and Emergency Preparedness Act waiver of liability for injuries from swine flu vaccines, which expired June 23. Here is the law describing duration of such waivers.  Thus one should be able to sue manufacturers for injuries sustained as a result of this season's flu vaccine.

However, a similar vaccine used in Australia caused one in 110 children to have a seizure recently, so its use was prohibited in children under five while a panel is investigating the possible cause.  Although US public health agencies are well aware of this problem, US authorities chose to recommend the same flu vaccine for all children aged over 6 months.

UPDATE: In the UK, according to the Telegraph, the Department of Health has written to all GPs to avoid giving flu vaccines from manufacturers CSL and Pfizer to children under five:

The letter to all GPs from Prof David Salisbury, said: "Epidemiological information from Australia indicates that there has been a higher than expected increase in febrile convulsions in children related to the use of Fluvax (manufactured by CSL).
"This is the same product that will be marketed in the UK by Pfizer as Enzira and generic influenza vaccine for the 2010/11 influenza vaccination season.
"Evidence from Australia suggests a rate of febrile convulsions of about one per 100 for children who were vaccinated with Fluvax. This increased risk appears to be a product specific reaction and evidence from Australia of vaccination with other products has so far not indicated a similar level of risk.
"It is important that children over six months of age who are in clinical risk groups receive influenza vaccination. Given the availability of other influenza vaccine products, you should avoid offering Enzira or CSL Biotherapies generic influenza vaccine marketed by Pfizer to children aged under five years."

Furthermore, CDC plans to roll out the shots earlier than usual this flu season, during August.  That makes little sense.

Seasonal flu epidemics almost never start before December.  It takes up to 2 weeks to get maximal immunity from one vaccine dose.  Immunity wanes rapidly.  Therefore, there is no reason to get vaccinated before late November.

Furthermore, there has been almost no swine flu in the southern hemisphere this 2010 flu season (their winter is our summer).  Only 5 cases have been recorded so far this season in Tasmania, which has a population of 500,000, of whom less than 1/3 have been vaccinated.  I wonder if a much higher proportion of the Australian and US population was exposed and became immune last year than the 20% reported.  Exposure gives you much stronger and longer-lasting immunity than vaccination.

So it is likely the swine flu component of the vaccine will be unnecessary.  Australians suspect that is what is contributing to adverse reactions.  Canadians might suggest the combination is unsound.  No one knows for sure.  There is plenty of time to observe the trends of viral activity, and the adverse effect profile of the vaccine, before those in the northern hemisphere need to make a decision about whether the vaccine is likely to provide them net benefit or harm.

July’s Toll Worst for U.S. Troops in Afghanistan/ NY Times

Excerpts from today's NY Times make clear the Afghans we are supposed to be helping do not appreciate us, to put it mildly.

KABUL, Afghanistan — The deaths of at least 66 soldiers, Marines, sailors and airmen have made July the deadliest-ever month for American troops in the nine-year war in Afghanistan. The tally includes six American service members who died in four separate attacks in southern Afghanistan on Thursday and Friday.

The growing toll follows a sharp increase in the American troop commitment that now stands at 95,000, along with a concerted effort by Taliban militants to slow major NATO offensives in the Taliban heartlands of southern Afghanistan. At least 265 American troops have died this year. The Web site icasualties.org reported 63 American deaths for July; a NATO official confirmed 3 additional American deaths on Friday.

Afghan casualties are rising as well, undercutting the support of Afghan society and complicating the military mission. In Kabul on Friday, a crowd of hundreds of Afghans rioted after a sport utility vehicle carrying American Embassy contractors struck a car of Afghans, killing at least three of them, the Afghan police said.

The riot happened early Friday afternoon on the busy road that connects the American Embassy and military headquarters in Kabul with the city’s airport.

The crowd chanted “Death to America” and “Death to foreigners.”...

The Imperial Presidency: Demanding Data on US citizens without a court order/ WaPo

 From the Washington Post:

The Obama administration is seeking to make it easier for the FBI to compel companies to turn over records of an individual's Internet activity without a court order if agents deem the information relevant to a terrorism or intelligence investigation.

... what officials portray as a technical clarification designed to remedy a legal ambiguity strikes industry lawyers and privacy advocates as an expansion of the power the government wields through so-called national security letters. These missives, which can be issued by an FBI field office on its own authority, require the recipient to provide the requested information and to keep the request secret. They are the mechanism the government would use to obtain the electronic records.

...To critics, the move is another example of an administration retreating from campaign pledges to enhance civil liberties in relation to national security. The proposal is "incredibly bold, given the amount of electronic data the government is already getting," said Michelle Richardson, American Civil Liberties Union legislative counsel...

The Imperial Presidency: Wresting $ power from Congress/ NY Times

Excerpts from the NY Times article titled, "Budget Chief Tried to Tilt Power to Executive Branch" by Matthew Bai:

Taken together, all of these proposals would seem to represent a clear exertion of executive power over the legislative branch from an administration that was supposed to have been more deferential to Congressional prerogatives.

Somewhere along the way toward wooing Congress, however, Mr. Obama seems to have decided that the problem, at least where reducing the cost of government is concerned, is Congress itself...  And so, in a variety of ways, the administration has deliberately set out to create alternatives...

Leading Democrats in the House aren’t arguing that the legislative process, with its dueling constituencies and parliamentary procedures, is necessarily the most efficient way to cut spending. But they maintain that it’s what the framers intended — and that subverting the process amounts to an assault on the democracy.

'Minister ignored advice over swine flu vaccine double dose plan'/ Dutch News

The Dutch health minister overbought swine flu vaccine, ignoring official advice of authorities in Holland.  What did WHO recommend at that point in time?  From Dutch News:

Health minister Ab Klink ignored advice from both the Dutch vaccine and public health institutes when he bought 34 million doses of swine flu vaccine last year, RTL news reports.
The tv programme says the vaccine institute told Klink that two shots per person would be unnecessary. And the public health institute warned Klink delivery would be too late for a mass vaccination programme...
In the end only young children, the elderly and some categories of workers were vaccinated, leaving 19 million doses of vaccine unused. Nearly 18 million of them are now in the process of being destroyed because they are past their 'use by' date...
It emerged last year that the country's chief virologist Ab Osterhaus, who advised the government to buy a double dose of the vaccine, has close links to drugs firms. He denied any conflict of interest.

Wikileaks fallout: Why are we continuing to support Pakistan? and only 33% of Americans are happy with Obama's handling of the war/ The Guardian

When we seem to be providing the operating expenses for those who bomb and shoot our children, what is the point of this war? From the Guardian:

... The leaks have focused attention on Afghanistan at a time when the Obama administration would rather concentrate on the economy – the main issue among voters – and have put pressure on him to explain why he thinks his new strategy will succeed where the old one failed. He is also facing pressure to explain continued financial, military and other support for Pakistan, despite allegations in the documents that elements in Pakistani intelligence are supporting the Taliban.

Members of Congress are becoming increasingly sceptical in public about the conduct of the war, and public support is falling. According to the latest Reuters/Ipsos, satisfaction with Obama's handling of the war has dropped to 33%, from 38% in January and 47% in February last year...

The Senate foreign relations committee held a hearing on potential talks with Afghan insurgents and a Senate armed services committee held a confirmation hearing on General James Mattis, who is set to replace Petraeus as head of Centcom. Mattis, who will have overall responsibility for the US military in the Middle East and Afghanistan, was reprimanded in 2005 for saying: "You go into Afghanistan, you got guys who slap around women for five years because they didn't wear a veil. You know guys like that ain't got no manhood left anyway, so it's a hell of a lot of fun to shoot them."

US military fails to account for 8.7 Billion in Iraq reconstruction money/ BBC

From the BBC:

Nine billion dollars "from the sale of Iraqi oil and gas, and some frozen Saddam Hussein-era assets" should have been in "a special fund administered by the US Department of Defense, the Development Fund for Iraq (DFI), and was earmarked for reconstruction projects.
But the report says that a lack of proper accounting and poor oversight makes it impossible to say exactly what happened to most of it.
According to the report, the Pentagon is unable to fully account for $8.7bn of funds it withdrew between 2004 and 2007..."

This is not the first time that allegations of missing billions have surfaced in relation to the US-led invasion of Iraq and its aftermath.
In 2005, the inspector general criticised the Coalition Provisional Authority, the US-led occupation administration, for its management of an $8.8bn fund that belonged to the Iraqi government.
A criminal investigation conducted led to the conviction of eight US officials on bribery, fraud and money-laundering charges.

Wikileaks Afghanistan documents: What do they reveal about the war?

Ninety-two thousand Wikileaks documents were provided in advance of their public release today to the NY Times, the Guardian (UK) and Der Spiegel (Germany). 

The NY Times opens with this comment: 

A trove of military documents made public on Sunday by an organization called WikiLeaks reflects deep suspicions among American officials that Pakistan’s military spy service has for years guided the Afghan insurgency with a hidden hand, even as Pakistan receives more than $1 billion a year from Washington for its help combating the militants.  Pakistan, an ostensible ally of the United States, allows representatives of its spy service to meet directly with the Taliban in secret strategy sessions to organize networks of militant groups that fight against American soldiers in Afghanistan, and even hatch plots to assassinate Afghan leaders...

The reports also chronicle efforts by ISI officers to run the networks of suicide bombers that emerged as a sudden, terrible force in Afghanistan in 2006.

Another NY Times article (there are several based on the leaked documents) says:

The documents — some 92,000 reports spanning parts of two administrations from January 2004 through December 2009 — illustrate in mosaic detail why, after the United States has spent almost $300 billion on the war in Afghanistan, the Taliban are stronger than at any time since 2001.

The article notes that Stinger surface to air missiles, supplied by the US for use by Afghanis against the Soviets in the 1980s, have been used to take down US aircraft in the current war.

The Guardian mentions hundreds of civilian fatalities caused by troops from the US, France, Poland, the UK etc., for "crimes" including that the bus they were riding in came too close to a convoy.  The Guardian also discusses "how US marines sanitised record of bloodbath."  The record is replete with many different coverups.

Democracy Now! also covers the leaks, in a roundtable discussion that includes Daniel Ellsberg (who leaked the Pentagon Papers almost 40 years ago).  The Pentagon Papers had a similar impact, in that they provided the military's unvarnished assessment of its plans and progress in the Vietnam War.

My hope is that these documents lead Americans to independently evaluate the costs of the war (in terms of prestige, treasure and the possibly permanent emotional effects such warfare is having on our own troops), what the best is that we could possibly gain as a nation from continuing the war, and what the justifications are for us to continue this war.

David Kelly death and the continuing Chilcott Inquiry into the leadup to the Iraq War

From the Express:

... Dr Fletcher, a highly ­respected retired pathologist and former chief scientific officer at the Department of Health, said: ‘‘From all the considerable reports I have read, Dr Kelly did not lose enough blood to cause his death.

“He would have had to lose three to four pints of blood but all the known evidence shows there was only a small amount at the scene. I don’t believe a coroner would determine he died of haemorrhage based on the ­evidence.”

Although an inquest was opened and a coroner assigned, it was decided that Lord Hutton himself would have the power to determine cause of death and that his public inquiry would ­effectively act as an inquest.  r Fletcher said: “With respect, Lord Hutton is not a coroner and there are many areas in the medical ­evidence which need to be analysed carefully by an actual coroner.

“There are so many unanswered questions that this Government should make it a priority to hold a proper and full inquest with people giving evidence on oath.” ...

From the Daily Mail:

... In addition, it was recently disclosed that Dr Kelly’s death certificate was not properly completed.
It was not signed by a doctor or coroner and does not state a place of death, leaving open the possibility he died somewhere other than where his body was found.
Furthermore, the pruning knife has been revealed to have had no fingerprints on it.
Campaigners are aggrieved by a mysterious decision to classify all evidence relating to the post-mortem for 70 years.
But they are encouraged by the fact that one of their most vocal supporters, Lib Dem MP Norman Baker, who has written a book questioning the Hutton verdict, is now a member of the Coalition as a Transport Minister.
A spokeswoman for Dominic Grieve said last night: ‘Mr Grieve expressed concerns about this issue when in opposition and has, since taking office as Attorney General, been exploring with ministerial colleagues any actions that may be taken.
‘No decisions have been made.’

Meanwhile, the Independent today discusses the conclusive evidence of the illegality of the 2003 Iraq war, which was made clear to Tony Blair before he went to war.  David Kelly's potential to place a monkey wrench in Tony Blair's inexorable march to war may have led to his death.

Hans Blix will testify to the Chilcott Inquiry Tuesday about his disagreements with Blair's claims about Iraqi weapons.  UPDATE:  Blix says after 500 inspections and no WMD found, Iraq war was clearly illegal.

Carne Ross was the UK's Iraq expert at the UN from 1997 to 2002.  He describes obstacles thrown up by the Foreign Office to limit his testimony to the Chilcott Inquiry in today's Guardian: specifically, he debunks the Blair claims about Saddam's nuclear capability and exaggerated claims of anthrax danger.  These were subjects David Kelly had also debunked (anonymously) to the BBC in 2003.  Kelly's death occurred several days after he was leaked as the source.

Playing by the rules, I had submitted my written testimony to Chilcot before my appearance. In the hours before my appearance, invited to visit the Foreign Office to see further documents (mostly irrelevant), an official repeatedly sought to persuade me to delete references to certain documents in my testimony.

He told me that the Cabinet Office wanted the removal of a critical reference in my evidence to a memo from a senior Foreign Office official to the foreign secretary's special adviser, in which the official pointed out, with mandarin understatement, that the paper sent that week to the Parliamentary Labour Party dramatically – and inaccurately – altered the UK's assessment of Iraq's nuclear threat.
In a clear example of the exaggeration of Iraq's military capabilities, that paper claimed that if Iraq's programmes remained unchecked, it could develop a nuclear device within five years.
The official's memo pointed out that this was not, in fact, the UK assessment: the UK believed that Iraq's nuclear programme had been checked by sanctions.
The paper to the PLP was instead sent by the foreign secretary to "brief" the wider cabinet. This paper was pure overstated propaganda, filled with ludicrous statements like "one teaspoon of anthrax can kill a million people". The paper was soon made public, as part of the campaign to create public hysteria...

There is a clear solution to these problems: break down the continued obstruction by the bureaucracy by releasing the documents – all of them. Only the most secret documents deserve continued protection, and there are very few of these. The vast majority of relevant documents relate to policy discussion inside the government before the war. Though profoundly embarrassing, there is little here that damages national security, except in the hysterical assessment of officials protecting their own reputation. Nick Clegg said a few weeks ago that almost all documents must now be released. He is right.

Last week, the Express reported that Mr. Blair has run up a bill for his security of 6 million pounds a year, courtesy of the British taxpayer.  That is about 25,000 dollars a day.  Tony's made sure there will be no David Kelly ending for him.

Swine Flu Fizzles Out; WHO May Declare End to Pandemic Alert/ Bloomberg

There has been almost no swine flu in the southern hemisphere so far this winter.  Finally WHO will announce we are in the post-pandemic phase.  From Bloomberg:

... More than $14 billion was spent on vaccines and medicines to fight the germ, which shared features of the Spanish flu of 1918 while causing little more than a fever and a cough in a majority of patients.

... Pharmaceutical companies reaped at least $10 billion in sales of vaccines and antivirals because of the outbreak, according to data compiled by Bloomberg. Roche of Basel, Switzerland, sold about $3.58 billion of Tamiflu last year and in the first three months of 2010. London-based GlaxoSmithKline Plc’s revenue from the pandemic reached $3.78 billion.  Novartis AG of Basel, Paris-based Sanofi-Aventis SA, CSL Ltd. of Melbourne and Baxter International Inc. of Deerfield, Illinois, also sold vaccines.

... The pandemic highlighted the unpredictable nature of influenza and showed that planning for responses to global outbreaks requires greater flexibility, Canterbury Health’s (New Zealand) Jennings said.

Closing schools and screening travelers at entry ports didn’t stop the virus, and the pandemic response wasn’t justified by its severity, said Heath Kelly, head of epidemiology at Victoria state’s infectious diseases reference laboratory in Melbourne, Australia.

Deviations from "Good Manufacturing Practices" the rule/ the Australian

An FDA inspection uncovered multiple significant deviations from standard manufacturing processes, termed "good manufacturing practices" at CSL (previously known as Commonwealth Serum Laboratories, and previously an Australian government lab) in its manufacture of flu vaccine for the US market.  As is standard in these cases, a disclaimer was made to the effect that there is no evidence any patients were harmed.

The story grew, after The Australian investigated inspections of Australia's pharmaceutical companies by the Australian equivalent of the FDA, the Therapeutic Goods Agency.  Of 139 sites inspected during the last financial year, only 3 were free of any deficiencies.  Corrective action was required at 136 sites.

I don't know how to find similar stats for the US.  Given that many Australian pharma companies are subsidiaries of US companies, they are likely to be similar.

UPDATE (The Australian):  DOCTORS are demanding an official all clear from the nation's drug regulator about the safety of swine flu vaccines. This follows US concerns over Australian pharmaceutical giant CSL.  Australian Medical Association vice-president Steve Hambleton yesterday said GPs were still waiting for the Therapeutic Goods Administration to officially inform them about discolouration in multi-use vials of the Panvax vaccine.

"We would want them to provide further reassurances that we can maintain our confidence in the stockpile which is in many doctors' surgeries around the country," he said.  The Australian revealed yesterday that the TGA had waited until US authorities blew the whistle on vaccine production at CSL's Melbourne laboratory in April, before launching its own inquiry into discoloration of the nation's stockpile of swine flu a month later. The TGA told The Australian on Wednesday that the remaining 9.4 million doses of Panvax stockpiled by the federal government did not pose a safety risk. Testing has failed to reveal the cause of the discoloration.
The US Food and Drug Administration has written to CSL criticising "deviations from current good manufacturing practice requirements", and singled out the presence of black particles in multi-dose vials of seasonal flu vaccine made for the American market. 

At the time of the US inspection, the TGA had suspended use of CSL's seasonal flu vaccine for young children after it had triggered febrile convulsions at nine times the usual rate. The TGA has ruled out any link between problems with the paediatric flu shot and the discoloration in the swine flu vaccine.  A CSL spokeswoman yesterday said the TGA "did not find any safety issues" in an audit of CSL's laboratories last month.

The Gillard government yesterday handed CSL, a listed company, $30m of taxpayer funds for research and development.

More than 100 Australian children suffered febrile fits before the seasonal flu vaccine -- a combination of seasonal and swine flu strains -- was suspended for healthy under-fives in April.

F.D.A. Panel Votes to Restrict Avandia/ NY Times

 Gardiner Harris @ the NY Times follows up on the FDA Avandia review:

A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.
The panel’s votes, taken after two days of intensive scientific discussions, were a blow to GlaxoSmithKline, which makes Avandia. The company argued that Avandia is a safe and needed option in treating diabetes.
But panel members voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public.
The panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the Food and Drug Administration should do. Of the panel’s 33 members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings...

FDA will then issue a decision in the near future.  One wonders why panel members would vote to restrict the drug's use, rather than taking it off the market, when Avandia does not appear to provide the benefits for which one treats diabetes:  a reduction in the consequences of the disorder. 

Gaming the Evidence: Evaluating adverse events post-vaccination/ BMJ rapid response

A letter to the BMJ questions the rationale for using certain new vaccines in India that fail to "result in significant reduction in disease burden" when older, cheaper and proven vaccines costing less than US $1.00 total per child are not being given to half the children in India.

The letter also unmasks a scam in the assessment of child deaths post-vaccination by a WHO expert panel.  The "Expert Panel was formed by the WHO Department of Immunization, Vaccines and Biologicals to provide expert advice on the potential causal association between selected serious AEFI (adverse event) cases reported in Sri Lanka in 2008 and the vaccines received by the affected infants." *

The expert panel did not perform its assessment away from the watchful eye of WHO.  "WHO/IVB (WHO Department of Immunization, Vaccines and Biologicals) staff served as secretariat to the Expert Panel to facilitate the review," according to the WHO Ad Hoc Expert Panel Report. *

WHO has standard criteria for making a causality assessment of post-vaccination adverse events.   The criteria are routinely used internationally.  However, in this case WHO's experts "deleted the categories Probable and Possible from the standard classification. All adverse events which could not be classified as Very likely/Certain were classified as Unlikely."

With this simple manuever, since they could not say causality was certain, the panel gave the impression that the vaccine was unlikely to be related to any deaths.  No explanation was given for why the WHO criteria were not used in this WHO study. 


*  WHO. Report of an ad-hoc WHO expert panel to review reports of serious AEFI following administration of pentavalent and other vaccines in Sri Lanka 2008 -- available at: http://jacob.puliyel.com/#paper_213.

Caustic Government Report Deals Blow to Diabetes Drug/ NY Times

The NY Times' Gardiner Harris has covered a crucial issue unpinning the use of drugs in modern medical practice.  As I point out on the left side of this blog:  "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 and use of vaccines, drugs and devices."

Harris' article points out that "the agency (FDA) rarely examines" some raw data from drug trials, which detail events occurring to individual subjects.  Due to continuing conflict over the safety of Avandia, FDA's "Dr. Thomas Marciniak took an unusually close look," demanding to see these records.  He discovered twelve serious cardiovascular adverse events that had been omitted from consideration, and "If given more time, he wrote, he would probably have found still more."

In my opinion, paying fines when such dishonest practices have been uncovered has done absolutely nothing to stop them.  Instead, the prices of drugs have risen steeply, and the fines are considered by Pharma to be the cost of doing business.  IMHO, until responsible drug company employees receive prison sentences when found guilty for making false claims about their products and hiding evidence of injuries, such practices will continue.

Excerpts from Harris' article follow.  A later Harris article on this subject was published July 12.

A federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.  Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the F.D.A. that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.

An editorial in The New England Journal of Medicine on Friday accused GlaxoSmithKline of interfering with the trial and said the system for hiring trial safety experts should change.

In an interview on Friday, Dr. Jerome P. Kassirer, a former editor of The New England Journal, said the Record trial raised the question “whether the entire system is corrupt.” “To the extent that we can’t trust the data,” he added, “we are in jeopardy of giving patients the wrong drugs.” 

Others within the F.D.A. say that observational studies are not good enough and that a well-controlled “prospective” study, like the one being conducted by GlaxoSmithKline, is the only sure way to answer whether Avandia is truly dangerous.

In a report released Friday, the Institute of Medicine, the nation’s leading medical advisory group, seemed to side with those who have argued that observational studies are adequate. Indeed, the group seemed to describe almost exactly a study of 227,571 Medicare patients conducted by an F.D.A. reviewer and published June 28 in The Journal of the American Medical Association concluding that Avandia increased the risks of stroke, heart failure and death compared with Actos.  The institute concluded that such studies “can sometimes provide higher-quality safety evidence than randomized controlled trials.”

Additional questions about the H1N1 scandal/ BMJ letter

French physician and pharmacoepidemiologist Marc Girard has penned a fiery letter to the BMJ about medical experts, clinical guidelines, drug regulation and the role of Pharma in creating a market for swine flu and hepatitis B vaccines.  Not to be missed, here are two excerpts:

...how, during the development of a vaccine targeted against a disease as mild as the H1N1 flu, the recording of no fewer than seven deaths in about 2000 healthy persons receiving Pandemrix as a test drug was regarded as acceptable?...

In 1997, in a widely circulated French journal [3], a Beecham’s business manager claimed: “We started increasing the awareness of the European Experts of the World Health Organization about hepatitis B in 1988 [emphasis added]. From then to 1991, we financed epidemiological studies on the subject to create a scientific consensus about hepatitis being a major public health problem. We were successful because in 1991, WHO published new recommendations about hepatitis B vaccination.” This speaks of exactly the same process as that which was uncovered by the BMJ/The Bureau of Investigative Journalism’s inquiry, namely: 1. WHO’s experts seem to need manufacturers’ salesmen to become “aware” of significant health problems; 2. recognition of “a major public health problem” involves commissioning epidemiological studies whose conclusions are apparently predetermined (“we financed epidemiological studies on the subject to create a scientific consensus”); 3. “new recommendations” are the main medium by which such commercial manipulations are effected, the long-term accuracy of which may be measured by the contrast between the initial skepticism of the BMA [4] and the views it expressed on the topic subsequently [5]. 

Scroll down to the last (2 July 2010) letter on this BMJ page for the full text.

The 2009 EMEA report of the Pandemrix safety and efficacy trials can be reviewed to investigate what was known of vaccine safety last year, but most of the data came from a "mock-up" H5N1 vaccine previously tested, not from H1N1 vaccine.  Seven subjects died during the trials: two in the group aged 18-60 and five in the group aged 61 and over.  One trial recorded post-vaccination fatigue in 50-60% of subjects and muscle aches in over 60%.  Very little information is provided regarding serious adverse events, except that most were thought by investigators to be unrelated to the vaccine.  However, when you are conducting trials in order to determine, in part, what the safety issues are for a new vaccine, you cannot dismiss any safety findings until you can compare the incidence of adverse events in cases and controls.  To do so during initial drug/vaccine studies is junk science (or unsupported opinion).

Daily Mail: David Kelly had an elbow injury and could not have cut his own wrist

Dramatic new testimony has heaped pressure on ministers to reopen the investigation into the death of Dr David Kelly.
A female colleague claims that the UN weapons inspector could not have committed suicide as claimed, as he was too weak to cut his own wrist.
Mai Pedersen, a U.S. Air Force officer who served with Dr Kelly's inspection team in Iraq, said a hand and arm injury meant that the 59-year-old even 'had difficulty cutting his own steak'.

... In a letter to the new Attorney General Dominic Grieve through her lawyers, Miss Pedersen also said Dr Kelly had difficulty swallowing pills, casting serious doubt on the Hutton Inquiry conclusion that he swallowed 29 painkillers before slitting his left wrist...

Read more: http://www.dailymail.co.uk/news/article-1291019/Dr-Kelly-slit-wrist-weak.html?ito=feeds-newsxml#ixzz0sa1UdF8n

"The Afghan War is Unwinnable" --Reps. Obey and Slaughter, in charge of the war funding vote

From the Washington Post:

...frustration with the war is so widespread that two lawmakers in charge of shepherding the bill through the House, Appropriations Committee Chairman David Obey (D-Wisc.) and Rep. Louise Slaughter (D-N.Y.), who heads the Rules Committee that establishes the procedures for votes on legislation, both said that the war is unwinnable and that they were merely fulfilling their duties as committee chairs in moving the funding toward a vote.   "If I had my way, I would never bring this to the floor," said Obey, whose committee presents spending bills to the broader House. "I believe this is a fool's errand."

... The funding bill, which passed by a vote of 215-210, would allocate money for equipment and support to troops in both countries, including the additional 30,000 Obama ordered there last December. The Senate must still approve the legislation, totaling about $80 billion. 

... Ninety-three Democrats, along with seven Republicans, backed an even more restrictive amendment from Rep. Barbara Lee (D-Calif.) that would allow the war funds to be spent only on withdrawing troops from Afghanistan. 

... "To me, the interesting thing about the Rolling Stone article was not about McChrystal, it was the general sense we'll never know what success looks like," said Rep. John Yarmuth (D-Ky.) who voted for the McGovern and Lee resolutions. "I'm not sure we will ever know we are winning."

Tossing away swine flu vaccine in the UK and US, and storing millions of Tamiflu doses

According to the AP. in the US, "the government placed three orders last year for a combined total of nearly 200 million doses — an unprecedented amount and almost double the amount of vaccine made in recent years for seasonal flu."

About a quarter of the swine flu vaccine produced for the U.S. public has expired — meaning that a whopping 40 million doses worth about $260 million are being written off as trash.

The UK wasted more than 1.2 billion pounds on swine flu, and now must slash healthcare jobs in response, according to the Mail Online:

More than £1.2billion of taxpayers’ money was spent on the swine flu pandemic that never materialised, a report has found...

Details of the scale of the cost emerge as the NHS is being forced to make drastic cuts, with hundreds of doctors and nurses’ posts at risk.

Stockpile: Millions of doses of Tamiflu are stacked ready for distribution in a British warehouse

At the height of the panic last year, ministers feared there could be as many as 65,000 deaths and ordered 90 million doses of the vaccine at a cost of £540million.
In fact yesterday’s report revealed that just 457 people died from swine flu – about a third of those killed every year by ordinary seasonal flu.

Many of those victims had underlying health conditions.
As a result, just 5.1 million doses of the vaccine were used, leaving the Department of Health with as many as 20million doses which will be out of date by October next year.

A report by the British Medical Association this week revealed that some hospitals are already axing up to 500 staff over the next year.   And last month it emerged that one in six primary care trusts has been forced to slash services after each spent an average of £340,000 preparing for swine flu.

Japan anticipates H1N1 vaccine loss at $853 million/Sankei

From Kyodo News:

TOKYO, Jun. 28, 2010 (Kyodo News International) -- Japan's Ministry of Health, Labor and Welfare said Monday it has agreed with Swiss drug maker Novartis (NYSE:NVS) AG to cancel part of a deal for H1N1 influenza vaccine because of a larger-than-expected surplus.
The cancellation agreement covers around 8.38 million doses, or 33.5 percent of the 25 million doses the pharmaceutical company had agreed to supply under a contract with the Japanese government.
With the cancellation, the government will save about 1.56 billion yen, although it will pay around 9.22 billion yen as an exit penalty, it said.
Japan has already received delivery of 16.62 million doses, worth 21.4 billion yen, which are set to expire on Wednesday, forcing the ministry to consider the timing and method of disposal.
Both parties have also agreed that if another flu epidemic occurs, Japan will be given priority in receiving up to 40 million doses of the vaccine.
France has similarly canceled about 44 percent of its vaccine deal with Novartis, while Italy is still negotiating but Holland has not cancelled.
Japan already cancelled part of another deal with GlaxoSmithKline Plc of Britain in March, making the total amount paid to the two pharmaceutical firms around 85.3 billion yen, less than the 112.6 billion yen it initially planned to pay.

The Sankai article is in Japanese.

Excellent: FDA Advises Against Routine Antibiotic Use in Animal Feed/WaPo

After decades of discussion, the most important step has been taken by FDA to reduce the emergence and spread of multidrug-resistant bacteria. From the WaPo:

"We have the regulatory mechanisms, and industry knows that," he said. "We also think things can be done voluntarily. We're not handcuffed to the steering wheel of a particular strategy, but I'm not ruling out anything that we can do to establish these important public-health goals."

Prior efforts of this kind "have repeatedly collapsed in the face of opposition from the drug industry and farm lobby..."

The European Union banned the feeding of antibiotics and related drugs to livestock for growth promotion in 2006.
U.S. farmers routinely give antibiotics to food-producing animals to treat illnesses, prevent infection and encourage growth. The drugs are often added to drinking water and feed. The Union of Concerned Scientists estimates that 70 percent of antibiotics and related drugs used in the United States are given to animals.

Many of the same classes of drugs fed to animals are deemed "critically" important in human medicine by the FDA, including penicillin, tetracyclines and sulfonamides. In recent years, public health experts say there has been an alarming increase in the number of bacteria that have grown resistant to antibiotics, leading to severe, untreatable illnesses in humans.

Europeans sniff at flu outbreak threats/ Financial Times

A Financial Times article tells us that Europeans are unlikely to want much flu vaccine this year.   But companies will do well regardless, in part because they will be able to use stocks of influenza antigen (made under contract for last season) in the coming season's flu vaccines.

Doctors: 29% don't want swine flu shot; another 29% not sure

UPDATE June 17 from the Times of India: "The imported doses of the swine flu vaccine, specially procured by the Union government for doctors and paramedical staff, have found few takers in Maharashtra. Only 811 of the state’s 34,300 medical staff involved in treating H1N1 patients took the shots..."

From The Telegraph, UK:
One third of doctors do not want swine flu vaccination, according to a new poll

The survey, carried out by Healthcare Republic for GP newspaper, found that almost three in 10 GPs said they would not have the swine flu vaccine, with the same number, 29 per cent, unsure whether they would or not.

Out of the 216 GPs polled, more than seven in 10 said they were concerned there had not been sufficient trials.

Richard Hoey, editor of Pulse, said: "The medical profession has yet to be convinced by the Government's whole approach to swine flu, with most GPs now feeling that the Department of Health overreacted in its policy on blanket use of Tamiflu.

Concern on Capitol Hill about Afghanistan war grows/ WaPo

From the Washington Post June 15:

... Senior military and defense officials, none of whom was authorized to discuss relations with the White House, said congressional questions and a series of negative stories in the media have increased requests for explanations...

Rep. Jeff Flake (R-Ariz.), a member of the House Foreign Affairs Committee who has traveled to Afghanistan, said he was "decidedly dubious" of the Obama administration's war strategy from the start. "I'm trying to see how a year from now we'll be in any better position than we are today. It's difficult for me to see a way out here."
Obama's war funding requests for this year and next are still awaiting approval, Flake said, and "it's going to be a more difficult sell than it was several months ago..."

WHO responds to the critics/ WHO

WHO has published a formal response on its website to many of the criticisms published in the BMJ and by the Council of Europe last week.

A few important points:

1.  WHO appears to acknowledge lack of disclosure of conflicts of interest by experts involved in its 2004 pandemic plan.

2.  WHO wiggles around the issue of pandemic severity, which was dropped from WHO's official definition of a pandemic, stating:

WHO regards severity as an important feature of pandemics and a critical factor when deciding on which actions to take. However, WHO has not required a set level of severity as part of its criteria for declaring a pandemic.

But declaring a level 6 Pandemic triggers actions to take.  Thus WHO's excuse is paradoxical.  As I noted earlier, the current definition encompasses any new common cold virus that leads to colds in different parts of the world.  Such a definition is entirely useless to public health efforts.  The process by which WHO experts came up with such an odd definition (which pulled the trigger for billions in vaccine/drug sales) should be explored.

3.  Part of WHO's justification for declaring swine flu a pandemic included the following:

The new H1N1 virus rapidly crowded out other circulating influenza viruses and appears to have displaced the older H1N1 virus. This phenomenon is distinctly seen during pandemics.

Agreed.  But then why was it recommended that citizens should receive both trivalent seasonal flu vaccine and swine flu vaccine?

There was virtually no circulation of seasonal flu strains (particularly the 3 strains for which the seasonal vaccine offered protection) yet vaccination with it was highly encouraged, to the point that more seasonal flu vaccine was used in the US last year than in any other flu season.  From CDC: (http://www.cdc.gov/flu/about/season/current-season.htm)

As of January 21, 2010, the predominant influenza virus in circulation is the 2009 H1N1 virus. More than 99% of all 2009 H1N1 viruses tested have been similar to the virus in the current 2009 H1N1 vaccine. Very few seasonal influenza viruses have been isolated and analyzed at CDC. For updated information about what viruses are circulating, visit FluView. CDC continues to recommend seasonal influenza vaccination to protect against seasonal influenza illness...

Furthermore, several Canadian studies suggested that receiving seasonal flu vaccine roughly doubled the risk of developing a swine flu infection.  Then why take chances with the seasonal shot when only swine flu is circulating?

If WHO and national public health officials were cognizant of how pandemics rapidly crowd out other flu strains, and closely observed this taking place, why was so much effort put into convincing people to get a useless seasonal flu shot last season?  Why did CDC encourage hospitals (and states) to require seasonal flu shots for their employees last season, when CDC knew that less than 1% of flu strains would respond to the vaccine?

Yet mandatory flu shots are "gaining traction" in spite of persistent questions as to whether they actually help prevent flu and flu deaths in the elderly and in hospitalized patients.

Pakistani agents 'funding and training Afghan Taliban' -- Why are we in Afghanistan, anyway?/ BBC

UPDATE June 14 (NY Times):  The United States has discovered nearly $1 trillion in untapped mineral deposits in Afghanistan, far beyond any previously known reserves and enough to fundamentally alter the Afghan economy and perhaps the Afghan war itself, according to senior American government officials.

It turns out that the information on Afghanistan's level of corruption (below) was felt to be so damaging by the Obama administration to its continued conduct of the war, that officials decided to release the information on what they really hope to extract from Afghanistan, even though at least some of Afghanistan's vast mineral deposits had been known about since the Soviet invasion during the 1980s:

American and Afghan officials agreed to discuss the mineral discoveries at a difficult moment in the war in Afghanistan. The American-led offensive in Marja in southern Afghanistan has achieved only limited gains. Meanwhile, charges of corruption and favoritism continue to plague the Karzai government, and Mr. Karzai seems increasingly embittered toward the White House.

Isn't it nice to learn what this war is actually about, after nine years and so many thousand US and Afghani lives have been lost?  This is what our tax dollars, children and national prestige were being spent on.

Some assert that Bin Laden and al Qaeda were pawns/creations of the CIA, used to get the Soviets out of Afghanistan. And some assert that Bin Laden and al Qaeda remained creatures of the US intel community at the time of 9/11.  (Sure, we had troops going after him, but he also made some amazing escapes.)  Was 9/11 the excuse to get us into Afghanistan so the US could gain control of its mineral wealth?  I will attempt to explore this question in future.

A new report by Harvard and London School of Economics authors on the Afghan conflict was discussed by BBC:

Pakistani intelligence gives funding, training and sanctuary to the Afghan Taliban on a scale much larger than previously thought, a report says.

Taliban field commanders interviewed for the report suggested that ISI intelligence agents even attend Taliban supreme council meetings.
Support for the Afghan Taliban was "official ISI policy" the London School of Economics (LSE) authors suggest...

Links between the Taliban and Pakistan's intelligence service have long been suspected, but the report's author - Harvard analyst Matt Waldman - says there is real evidence of extensive co-operation between the two.

"This goes far beyond just limited, or occasional support," he said. "This is very significant levels of support being provided by the ISI. "We're also saying this is official policy of that agency, and we're saying that it is very extensive. It is both at an operational level, and at a strategic level, right at the senior leadership of the Taliban movement."

Last week Afghan intelligence chief Amrullah Saleh resigned, saying he had become an obstacle to plans to talk to the Taliban.

Mr Saleh told Reuters news agency a day after quitting that the ISI was "part of the landscape of destruction" in Afghanistan and accused Pakistan of sheltering Taliban leaders in safe houses... 

The BBC's Quentin Sommerville in Kabul says there is a growing understanding that military action alone will not be enough to bring peace in Afghanistan...

Preventing iatrogenic pandemics of panic/ BMJ

June 9 BMJ article by Luc Bonneux and Wim Van Damme:

The decisions to stockpile antivirals and influenza vaccines to control avian flu (2005-6) and swine flu (2009) cost large amounts of money.^{1 2} Both epidemic threats were mostly iatrogenic pandemics of panic, which caused little human suffering, but the global plans to control them were largely a waste of money.¹ Was this the consequence of rational risk management in conditions of uncertainty, of fear accompanying any epidemic threat,³ or of close working relationships between disease experts and the drugs industry?
Severe acute respiratory syndrome (SARS) in 2003 was an epidemic by an unknown and therefore scary new virus, but we know much more about influenza viruses.^{2 4 5} The new A/H1N1 swine flu was a far cry from the lethal A/H1N1 pandemic of 1918. There has never been evidence that the recent A/H1N1 virus was anything but mild,⁶ and it was not reasonable to consider it the first wave of a much more serious second wave. The theory that the 1918 influenza pandemic was caused by a second wave of a mutated virus that had caused a benign epidemic in a first wave has never been supported by any evidence.⁴ The nature of the organisms that caused mild respiratory disease in the spring of 1918 is unknown, but many better candidates than a "Spanish influenza virus light" exist. Both recent iatrogenic pandemics of panic were caused, or at least exaggerated, by disease expert committees.
The core of health economics and health policy is that resources are scarce. If resources were infinite, all possible measures could be taken to fight disease, including prevention of all hypothetical possibilities. Because resources are limited, wise allocation saves lives...

The World Health Organization failed to give appropriate guidance in both pandemics of panic. To prevent this from recurring, WHO should "do it the NICE way." Disease experts are necessarily and fatally biased. It is not reasonable that they bear the entire responsibility for decisions related to their disease. This has been convincingly shown over the past years with the two iatrogenic pandemics of influenza panic. Advice of disease experts, of course, is valuable and indeed crucial, but this advice should be tested against the available evidence, balanced by other stakeholder views, and checked by the transparent evaluation of costs and values. At last, the final evidence based policy advice should be drafted by independent scientists trained in evaluation and priority setting.

Why is Swine Flu Still a Level 6 Pandemic?/ CDC

Here is the WHO report on current Swine Flu activity wordwide, and below is the CDC report for the US.

Swine Flu pandemic response due to conflicts of interest? Journal Nature rebuts this claim

Nature's Declan Butler examines and rebuts the claim that WHO experts' paid consultancies affected the advice they gave WHO on the swine flu pandemic.  Butler correctly notes that many governments ordered some swine flu vaccine before WHO declared a Level 6 Pandemic.  He further reports that scientists said, "severity is impossible to pin down until many months after [a pandemic] starts."  Another issue he discusses is whether WHO and its experts had declared their conflicts of interest correctly.

Yes, some swine flu vaccine was purchased prior to WHO's June 11, 2009 Pandemic Level 6 declaration.  But what has not been adequately discussed anywhere, to my knowledge, are pre-existing contracts that were forcibly triggered by the declaration of a Level 6 Pandemic.  Such contracts had been entered into by governments and vaccine manufacturers as a result of earlier fears [circa 2000-2004] over a potential avian flu pandemic disaster.  The contracts allegedly committed governments to large purchases of "pandemic" vaccines, no matter what pandemic eventuated.  WHO knew of these contracts, and both its officers and expert consultants understood that billions of dollars in vaccine purchases hung on the decision to declare a Level 6 Pandemic.  These contracts were not made known to the public at the time.

I would posit that by June 11, 2009 the epidemic looked a lot tamer than it had in April 2009. WHO's Margaret Chan discussed severity when she declared a Level 6 Pandemic, acknowledging, "On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment." 

 I would further posit that although discussions about the definition of pandemic had been ongoing, the decision to omit severity from the definition is, at a minimum, medically unsound.  The current WHO definition allows for every widespread new common cold virus to be termed a Level 6 pandemic.  Thus the altered definition lacks specificity and therefore lacks usefulness.

Given the knowledge of disease severity in June 2009, compared to April 2009, there was no clear public health need to raise the pandemic level and activate the preexisting vaccine contracts.  Recall that those contracts had been written when a bird flu pandemic, associated with a 50% plus case fatality rate, had been envisioned.   Probably many of the same people were involved in the swine flu response as were involved with bird flu planning and response.  Certainly Doctors Margaret Chan (China) and Keiji Fukuda (USA) (respectively WHO Director-General and Deputy Director-General, both from countries where vaccine makers were located) were central to the response to both pandemics.

One would have expected these experts to distinguish the enormous difference in severity between the bird and swine flu pandemics, and respond accordingly.  Scuttlebut at the time of WHO's June 11 declaration was that different countries had been jockeying to influence the decision, suggesting that politics influenced the declaration.  WHO Director-General Chan says that, "At no time, not for one second, did commercial interests enter my decision-making," Okay.  But then, what did lead Dr. Chan to raise the pandemic level last June?  And what has led her to retain that designation today, when there is no serious swine flu pandemic anywhere?  Given that the current (absent) state of swine flu disease is still being called a maximum Level 6 Pandemic by WHO, I'd advise countries with pandemic vaccine contracts that will be activated by future WHO pandemic designations to scuttle those contracts, asap. 

I beg to differ with Butler's experts, who claimed that months were needed to assess swine flu severity.  When you are dealing with a potentially calamitous situation, and directing huge amounts of resources to understanding and controlling it, you can get a very good handle on mechanisms and ease of spread, as well as disease severity, in a very few weeks (and sometimes days), as long as the incubation period is short, as this one was.

As to the issue of experts' conflicts of interest:  these are pervasive throughout governments and international organizations.  It has been very hard to find any expert advisors on FDA, CDC and WHO advisory panels (WHO has kept its pandemic flu emergency committee members a secret) who have not regularly consulted for industry.  This is a recent cultural phenomenon, and it appears to be changing at FDA, following Congressional investigation.  No one knows how to measure or manage the inherent conflicts, so they are mostly ignored.  To what extent they influence decision-making remains to be seen.  Personally, I feel such conflicts have been instrumental in dismantling safety standards and weakening government oversight (for example, by insufficient safety testing of swine flu vaccines before distribution, and not properly overseeing oil well construction).

Report condemns swine flu experts' ties to big pharma/ Guardian

From the Guardian's Randeep Ramesh:

Scientists who drew up the key World Health Organisation guidelines advising governments to stockpile drugs in the event of a flu pandemic had previously been paid by drug companies which stood to profit, according to a report out today.

An investigation by the British Medical Journal and the Bureau of Investigative Journalism, the not-for-profit reporting unit, shows that WHO guidance issued in 2004 was authored by three scientists who had previously received payment for other work from Roche, which makes Tamiflu, and GlaxoSmithKline (GSK), manufacturer of Relenza.

 City analysts say that pharmaceutical companies banked more than $7bn (£4.8bn) as governments stockpiled drugs. The issue of transparency has risen to the forefront of public health debate after dramatic predictions last year about a swine flu pandemic did not come true...

And from the AP:

PARIS — A report released by the Council of Europe on Friday accuses the World Health Organization and European governments of vastly exaggerating the public health risks of swine flu and making secretive decisions that benefited pharmaceutical companies.
WHO, the U.N. health agency, has said those who claim swine flu was a fake pandemic created for the benefit of drug companies are irresponsible...

9 x increase in seizures after swine flu vaccine: Australian gov't investigation

INVESTIGATOR: Australian Nobel Prize winner Professor Peter Doherty is leading an investigation into Australia's baffling spike in severe side-effects from flu jabs. 

From Perth Now:

SEASONAL flu shots can trigger febrile fits in young children at nine times the expected rate and should not be given to healthy under-fives this winter, the Chief Medical Officer advised yesterday in a warning that puts the world on alert.

Australia's baffling spike in severe side-effects may jeopardise the roll-out of the 2010 flu vaccine in the northern hemisphere, where the US, the European Union and Canada are awaiting the results of an investigation to be led by immunologist Peter Doherty.

 From The Australian:

Chief Medical Officer Jim Bishop said the 2010 seasonal flu shot had triggered febrile convulsions at a rate of nine in every 1000 children younger than five -- nine times the expected rate. [Nearly 1 in 100 young kids had a seizure:  a rate unheard of for other vaccines. The CSL vaccine is the one used in Australia, and it is unknown whether other manufacturers' vaccines cause the same, or other, complications--Nass]

The head of Australia's investigation into the spate of serious side-effects from the suspended pediatric vaccine said one hypothesis was that the killed-off cells were causing a "cytokine storm" -- a severe overreaction to the vaccine by healthy children's immune systems.
Such reactions have been blamed for the death toll from the 1918 Spanish flu pandemic. Professor Doherty told The Australian the vaccine "could be doing something along those lines".

Pharmaceutical giant CSL yesterday announced a voluntary recall of the pediatric version of its Fluvax seasonal flu vaccine from medical clinics and distributors, as a "precautionary measure".

From Perth now:

The federal government has appointed Professor Doherty -- who shared the Nobel Prize in medicine in 1996 - to lead a committee of experts who will collaborate with the US Centre for Disease Control in Atlanta.
"Everyone is interested in what we're discovering, and we will be making information available to our colleagues at the WHO, the US and Canada," Professor Bishop told The Australian yesterday.
"The EU Centre for Disease Control has been in contact and we've had teleconferences with them. Our information is important to them, and they are going to take our findings into account."

Instead, the CDC tried to drown out this information today, blitzing the media with the claim (from the Atlanta Journal-Constitution):  CDC:  Swine Flu Vaccine Proved Safe.

But this isn't true.  The truth, discussed later in the article, is that swine flu vaccine caused the same amount of extra Guillain Barre Syndrome (GBS) cases as seasonal flu vaccine causes:  one more case than would otherwise occur per million vaccinated.

... analysis by the Atlanta-based Centers for Disease Control and Prevention revealed that about the same rate of people contracted GBS after receiving this recent swine flu vaccine as have historically contracted it from common flu vaccine.

But never mind the truth, when CDC is trying to reassure nervous parents that this year's vaccine couldn't possibly cause children to have seizures.  “Ongoing CDC research continues to show that the 2009 H1N1 flu vaccine is safe," CDC spokeswoman Rosa Herrera said. "Data show that the vaccine’s safety profile looks similar to the time-tested profile of seasonal flu vaccine.”

CIDRAP (U. Minnesota) makes clear CDC's data are preliminary and based on unconfirmed phone surveys (!)

Environmental Agents Trigger Autoimmune Thyroid Disease/ Medscape

From the Medscape report from the American Thyroid Association Meeting:

Multiple genetic and environmental risk factors can trigger autoimmune thyroid disease in humans, according to experts here at the American Thyroid Association (ATA) Spring 2010 Meeting.
Gregory A. Brent, MD, professor of medicine and physiology at the David Geffen School of Medicine at the University of California at Los Angeles, presented the findings.
He reported that "genetic background accounts for about 70% of the risk for autoimmune thyroid disease. The remainder is likely related to a range of environmental triggers."  [So if you have a family background of autoimmunity, you are generally at higher risk for developing thyroid disease after certain exposures, including vaccines.  Mandating vaccines for people from such families genetically discriminates against them, as they are at much higher risk of a severe adverse reaction than people from families without autoimmune disease.--Nass]
A number of toxicants affect iodine uptake and thyroid hormone synthesis, metabolism, binding, and action, he explained.
He noted that among the more common agents that affect thyroid metabolism are perchlorates (a rocket fuel additive), thiocyanates (a compound in cigarettes), and dioxins (a class of pesticides). Few studies assess how these agents affect humans, he added.
"The problem is that most of these thyroid toxicants have been identified in vitro and in animal models. The significance for humans is much more difficult to assess," said Dr. Brent...

The thyroid is influenced by toxicants. Researchers know very little about their effects in humans. These compounds include polychlorinated biphenyls (PCBs), pesticides, polybrominated diphenyl ethers (PBDEs), and bisphenol A (BPA).

Autoimmune hypothyroidism has been shown to be a consequence of vaccination in dogs.  Many Gulf War veterans and anthrax vaccine recipients have developed thyroid disorders, usually hypofunction but also Graves' disease and thyroid cancers.  Raw thyroid cancer rates in servicemembers before and after receiving 1-3 anthrax vaccine doses revealed that cancer rates tripled after vaccination.  See tables G1-G3 of the IOM report.

"Incidents" at Fort Detrick, 2009: 17 infectious exposures of personnel/ Frederick News-Post

The local Frederick News-Post filed a FOIA to learn the number and type of infectious incidents and injuries that had been reported over the past few years.  Last November an employee was sick with tularemia for 3 weeks before being diagnosed,  Most likely she inhaled the bacteria.

Examples incllude the following:

Of the 16 reports that involved a potential exposure to viruses or bacteria, three workers were bitten or scratched by an animal, two were pricked by a needle and three were splashed by contaminated liquids.
Three workers each filed a report for a Feb. 9 incident involving a mouse that had been exposed to Yersinia pestis, the bacterium that causes the plague. One worker was weighing the mouse's spleen and dropped the petri dish containing the possibly infected organ. None of the three workers was wearing any respiratory protection, so they were put on antibiotics until the spleen tested negative for Yersinia pestis. After this accident, USAMRIID decided workers would weigh tissue in snap-cap vials instead of petri dishes.
Last June, a lab technician working with a primate infected with the Ebola-Zaire virus noticed a 1-centimeter tear in the right index finger of the worker's protective blue suit. The inner glove had not been punctured, and the technician's finger had no breaks in the skin, so the incident was deemed to have "negligible risk of disease."

What this demonstrates all too vividly is that when working with live animals the protective, high-containment suits are inadequate to prevent infectious exposures via bites and scratches.  Stuff happens, and workers are not always prepared with respiratory and eye protection for splashes or simply inhaling the bugs they study.  Work-related infections are sometimes not diagnosed early enough to prevent exposure to the surrounding community.

The NY Times looked at the safety issue over the entire industry, in "Safety Rules Can't Keep UP With Biotech Industry:

One study, reviewing incidents discussed in scientific journals from 1979 to 2004, counted 1,448 symptom-causing infections in biolabs, resulting in 36 deaths. About half the infections were in diagnostic laboratories, where patient blood or tissue samples are analyzed, and half in research laboratories.
But that may be a “substantial underestimation,” the study’s authors wrote, because many incidents are never made public. The study was done by two biosafety experts and published in the book “Biological Safety: Principles and Practices.”

BP's Top Kill: Just gimme some truth/ NY Times

From the NY Times:  Both BP and multiple government spokespersons told the world this am that the top kill procedure was going well.  Not until late afternoon was the truth told:  the process had been aborted the night before:

As hour after hour passed after the top kill began early Wednesday afternoon, technicians along with millions of television and Internet viewers watched live video images showing that the dark oil escaping into the Gulf waters was giving way to a mud-colored plume.
That was an indication that the heavy liquids known as “drilling mud” were filling the chambers of the blowout preventer, replacing the escaping oil.
In the morning, U.S. officials expressed optimism that all was going well. “The top kill procedure is going as planned, and it is moving along as everyone had hoped,” Coast Guard Adm. Thad Allen, the leader of the government effort, told CNN Thursday morning.
And Robert Dudley, BP’s managing director, said on the NBC Today Show on Wednesday morning that the top kill “was moving the way we want it to.”
It was not until late afternoon that BP acknowledged that the operation was not succeeding at halting the leak, and that pumping had halted at 11 p.m. Wednesday night.

Bush-Blair (and now Obama) assault on civil liberties being overturned in the UK/ Glen Greenwald

Over the past months, I have been dismayed, and then alarmed, by the continuing erosion of civil liberties in the United States.  My recent op-ed noted that of the ten guaranteed freedoms granted by our Founders in the Bill of Rights, at least four have been regularly trampled (if not completely trashed) by the federal government in recent years.  Here is one powerful example:

According to attorney Glenn Greenwald,

One of the first acts undertaken by the Obama DOJ that actually shocked civil libertarians was when, last February, as The New York Times put it, Obama lawyers "told a federal judge that military detainees in Afghanistan have no legal right to challenge their imprisonment there, embracing a key argument of former President Bush’s legal team."

But last April, John Bates, the Bush-43-appointed, right-wing judge overseeing the case, rejected the Bush/Obama position and held that Boumediene applies to detainees picked up outside of Afghanistan and then shipped to Bagram.  I reviewed that ruling here, in which Judge Bates explained that the Bagram detainees are "virtually identical to the detainees in Boumediene," and that the Constitutional issue was exactly the same:  namely, "the concern that the President could move detainees physically beyond the reach of the Constitution and detain them indefinitely."  

But the Obama administration was undeterred by this loss.  They quickly appealed Judge Bates' ruling.  As the NYT put it about that appeal:  "The decision signaled that the administration was not backing down in its effort to maintain the power to imprison terrorism suspects for extended periods without judicial oversight."  Today, a three-judge panel of the D.C. Circuit Court of Appeals adopted the Bush/Obama position, holding that even detainees abducted outside of Afghanistan and then shipped to Bagram have no right to contest the legitimacy of their detention in a U.S. federal court, because Boumediene does not apply to prisons located within war zones (such as Afghanistan).

So congratulations to the United States and Barack Obama for winning the power to abduct people anywhere in the world and then imprison them for as long as they want with no judicial review of any kind...

Greenwald, in another article, reports that the new Coalition government in the UK has published its platform for the world to see.  And it is chock full of promises to restore British civil liberties!  Have a look at this amazing document.  Under the "Civil Liberties" section it says:

 "The Government believes the British state has become too authoritarian, and that over the past decade it has abused and eroded fundamental human freedoms and historic civil liberties."

The UK government's new platform promises to"roll back state intrusions," "scrap the ID card scheme," "outlaw the fingerprinting of children at school without parental permission," "defen[d] trial by jury," and establish a Commission to investigate the creation of a Bill of Rights that incorporates and builds on all our obligations under the European Convention on Human Rights... and protects and extends British liberties."

Thank God for the sanity of our friends across the Pond.  Maybe someday we will follow in their footsteps and restore the rights that our Constitution granted?

UPDATE May 27 from Raw Story:  Britain Scrapping ID Program:  

LONDON — The new coalition government is to scrap a national identity card scheme introduced by former prime minister Gordon Brown's administration, it announced Thursday.
The scheme will be abolished within 100 days under legislation presented by Home Secretary Theresa May, the first bill to be introduced to parliament by Prime Minister David Cameron's government.  The expected new legislation "is the first step of many that this government is taking to reduce the control of the state over decent, law-abiding people and hand power back to them," said Home Secretary May.  "With swift parliamentary approval, we aim to consign identity cards and the intrusive ID card scheme to history within 100 days," she said.

Anthrax vaccine recipients in Israel developing Crohn's Disease/ Haarretz

From Haaretz:

The (Israeli) Defense Ministry has recognized a former soldier who participated in the army's experiments on an anthrax vaccine as a disabled veteran after he developed Crohn's disease. For two years, it denied similar recognition to another veteran who has the same disease, which causes severe bowel infection (sic), and participated in the same experiments, until a court overruled that decision last month. The ministry said the cases differed, as the first soldier contracted the disease during the experiment and the second only three years later. Altogether, 716 soldiers took part in the trials from 1998-2006, and many later said they were pressured to "volunteer." Many have also since developed medical problems.

Well guess what?  US recipients of anthrax vaccine also have statistically significant raised rates of Crohn's disease, according to Defense Medical Surveillance System data provided to the Institute of Medicine in 2001.   Is anyone surprised?  Yet every US soldier being deployed still receives multiple anthrax vaccinations (the initial course is 5 doses over 18 months).  The original excuse was that Saddam might use anthrax (we gave him some:  strain Vollum 1B) on our troops.  Saddam is gone, but the combination of inertia, and a vaccine manufacturer that knows how to grease palms, continues to disable vulnerable members of the US military.

How much swine flu vaccine was truly used? What does CDC's numbers game tell us?

Here are some anomalies in CDC's reported data.  Note that all the data come from information provided by CDC on April 1-2, 2010 (using the same dataset) and were said to reflect information through January (MMWR) or February (per Schuchat) 2010.

1.  Local reporting (May 18) has it that New Jersey used 1.14 million doses of swine flu vaccine;  65% was given to children.  New Jersey has 8.7 million inhabitants.   If everyone got one dose, 13.1% of the population would have been vaccinated.  But children 6 months through 8 years were advised to receive two doses.  So the percentage of vaccine recipients is less than 13.1%.  Yet CDC estimated that 17.8% of New Jersey residents were vaccinated.

Surprisingly, on April 1, CDC's Ann Schuchat claimed the state with the lowest vaccination rate was Mississippi, at 13%.  Mississippi has the lowest per capita income in the US.  New Jersey has the second highest.  It is very unlikely that New Jersey had as low a vaccination rate as Mississippi.  At least one of these numbers is wrong, and I'm betting that Mississippi's rate is exaggerated upward.

2.  New Jersey has given us a real number, unlike CDC, which can only cite telephone surveys of how many people said they got vaccinated.  Based on these surveys, 72 to 81 million Americans received swine flu vaccinations.  Yet, as I've noted previously, every office that received swine flu vaccine from CDC (and there was no other way to get this vaccine in the US) was required to file weekly reports with CDC providing the precise number of doses administered.  Although I have searched at length (on CDC's website and in the media) for the number of vaccinations reported to CDC by medical providers, I can find no mention of it.

3.  According to CDC's Ann Schuchat (on April 1, 2010), "The elderly, 22 percent of them, were vaccinated compared with only 14.4 percent of healthy adults under 65."  For children under 18, she said the vaccination rate was 36.8%.  CDC attributed this to school-based vaccination clinics.  [Read the transcript of her press conference to get a flavor for how Dr. Schuchat dodged questions and spun answers, and implied CDC would encourage employer vaccine mandates for healthcare workers.]

The USA has 75 million children under 18.  That is 27.6 million kids vaccinated (36.8%).  Those over 65 comprise 12.6% of the population of 309 million, or 38.9 million.  8.57 million (22%) were vaccinated.  Those 18-65 in the US number 195 million.   28.1 million of them (14.4%) were vaccinated.

The grand total of vaccinated Americans provided on April 1, 2010, calculated using CDC's vaccination rates for different age groups, is 64.3 million Americans, not 72 to 81 million, as claimed by CDC. [With all CDC's resources, it still can't get its story straight.]

4.  There is no way to know if the vaccination rates by age that CDC provided are accurate, if they are gross approximations or fabrication.  It is a crying shame that federal agencies are under no compulsion to tell the truth.  This is imho worse than lying--because CDC used millions of taxpayer dollars to fund phone surveys asking people if they were vaccinated, in order to develop incorrect estimates of the number vaccinated:  because CDC did not want to provide the correct number to the public.  I call that adding insult to injury.

5.  For another topical example of CDC duplicity and its adverse effect on the public health:  CDC admitted last Friday that it had misled the public about the risk of lead in the District's drinking water.  (The agency is a habitual liar.)  According to the Washington Post:

Sometimes Don Quixote beats the windmill.

It happened for Marc Edwards, a lean, intense Virginia Tech environmental engineering professor. Drawing on what he called his own "world-class stubbornness," he mounted a six-year campaign that succeeded last week in forcing the federal Centers for Disease Control and Prevention to admit that it had misled the public about the risk of lead in the District's drinking water.

The CDC, which is the nation's principal public health agency, made the confession in a "Notice to Readers" published in an official weekly bulletin Friday. It came a day after a scathing House subcommittee report said the agency knowingly used flawed and incomplete data when it assured D.C. residents in 2004 that their health hadn't been hurt by spikes in lead in the drinking water. . .

Edwards's effort cost him thousands of hours away from his young family in Blacksburg. Officials at the CDC and the EPA tried to smear his professional reputation, dismissing him as just an engineer rather than a qualified health professional.

For a while, the crusade cost Edwards money as well. In 2004, he passed up a $100,000 EPA contract to consult on the issue, because he felt that he would be working for the wrong side. He put his family in debt by spending tens of thousands of dollars, mostly on fees for endless Freedom of Information Act requests to get data critical to his research. . .

Edwards said the key breakthrough came in early 2008. That's when he finally persuaded Children's National Medical Center to share data so he could do an independent study of lead levels in D.C. children's blood samples. The CDC and other agencies were refusing to provide him with such information. . .

That study blew a hole in the CDC's 2004 report. The agency had said "no children" were identified with elevated, unsafe blood levels, "even in homes with the highest water lead levels."

The CDC now concedes that its scientific credibility has suffered a blow. It blames the problem largely on poor writing in the report. "Looking backward six years, it's clear that this report could have been written a little better," said Tom Sinks, deputy director of the CDC's national center for environmental health.

Edwards said the CDC is still trying to hide its misdeeds. "There's a lot of lessons here for how science can go awry, how bureaucracies can use science to hide the truth," Edwards said. . .