Saturday, July 31, 2010

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 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.”...

Wednesday, July 28, 2010

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.

Tuesday, July 27, 2010

'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.

Monday, July 26, 2010

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.

Saturday, July 24, 2010

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.

Tuesday, July 20, 2010

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.

Monday, July 19, 2010

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.

Wednesday, July 14, 2010

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. 

Monday, July 12, 2010

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:

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.”

Saturday, July 3, 2010

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:, 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).

Friday, July 2, 2010

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...

"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.