Yet even as regulators investigate the causes of the Deepwater Horizon disaster, the broader dangers posed by the industry’s push into deeper waters have gone largely unscrutinized.
“Our ability to manage risks hasn’t caught up with our ability to explore and produce in deep water,” said Edward C. Chow, a former industry executive who is now a senior fellow at the Center for Strategic and International Studies...
Underwater, both powerful currents and mudslides play havoc with delicate equipment and the pipelines that bring oil and gas back to shore.
The water temperature, which hovers at just above freezing at depths below 3,000 feet, can harden natural gas into crystallike structures called hydrates that can clog pipelines and other equipment. And because the wells are deeper than human divers can go, oil companies must rely on remote-controlled submarines to maintain their equipment or perform repairs.
Problems are more common than the industry likes to admit... Hurricanes are a constant menace. Hundreds of offshore platforms and pipelines were destroyed by hurricanes Rita and Katrina in 2005, shutting down the gulf’s entire oil and gas production for weeks. A Shell platform called Mars was badly damaged when its drilling rig tumbled over in Hurricane Katrina, shattering equipment, living quarters and the steel pipes that girdle all facilities. The two pipelines that take Mars’s oil and natural gas to shore were also badly damaged...
Under a $1 billion initiative announced in July, four oil majors — Chevron, ConocoPhillips, Exxon and Shell — said they would design and build equipment that could be used to contain and cap well blowouts at depths of up to 10,000 feet. However, they say the new devices will not be tested and ready for 18 months, and the plan is not likely to work in places outside the gulf, like Alaska, where conditions differ...
Monday, August 30, 2010
Risk-Taking Rises as Oil Rigs in Gulf Drill Deeper/ NY Times
Excerpts from today's NY Times:
EMEA starts review of Pandemrix, will consider provisional measures at its September meeting
From Therapeutics Daily:
... Although the cases of narcolepsy have been reported in temporal association with the use of Pandemrix, it is at present not known if the vaccine caused the disorder. The Agency’s Committee for Medicinal Products for Human Use (CHMP) will look carefully at all of the available data to determine whether there is evidence for a causal association. As part of this evaluation the Committee will also consider the so-called background rate for narcolepsy, i.e. the number of cases that would normally be expected to be diagnosed.The Committee will be working with experts from across the EU to assess this possible safety concern and any impact on the benefit risk balance of Pandemrix. The Committee will consider at its September 2010 meeting the need for any provisional measures pending completion of the evaluation.The Agency is also liaising with the European Centre for Disease Prevention and Control (ECDC), international regulatory partners and the World Health Organization (WHO).The European Medicines Agency will provide updates as new information becomes available.
Saturday, August 28, 2010
David Kelly, A Textbook Suicide? Mail and Independent
Hmmm. What exactly is a textbook suicide, Dr. Nicholas Hunt? The most common suicide in males would be associated with alcohol excess and a gun death. Suicide attempts do frequently involve use of more than one drug in large quantities, but I have never seen someone try drugs and cutting an artery at the same time. If Kelly died of blood loss, which seems very unlikely, the blood had to go somewhere, but it hasn't been found.
So if he didn't die from blood loss (you have about a gallon of blood per person, and roughly more than half needs to be lost before you die... we frequently see patients with more than half gone from gastrointestial blood loss and they almost always live) and the blood levels of drugs were way below fatal levels, what did cause Dr. Kelly's death? If he died of a cardiac arrest due to blood loss, there needs to be evidence to support the diagnosis.
According to The Independent:
So if he didn't die from blood loss (you have about a gallon of blood per person, and roughly more than half needs to be lost before you die... we frequently see patients with more than half gone from gastrointestial blood loss and they almost always live) and the blood levels of drugs were way below fatal levels, what did cause Dr. Kelly's death? If he died of a cardiac arrest due to blood loss, there needs to be evidence to support the diagnosis.
According to The Independent:
In his fascinating book The Strange Death of David Kelly, Norman Baker, now the transport minister, raises the interesting question of why Dr Hunt, relatively inexperienced at the time, should have been chosen to deal with what was a sensational case.From the Mail we find the following:
Earlier this month, the Attorney General Dominic Grieve signalled that he is prepared to intevene, saying that those people who now want a new investigation into Kelly's death should not be dismissed as conspiracy theorists.For more detail about multiple issues raised by the Mail, go here.
The truth is that Hutton failed to fulfil his remit to 'urgently examine the circumstances surrounding the death of David Kelly'.
Instead, his inquiry concentrated on the roles played by Mr Blair and his advisers, concluding that they had no reason to feel any guilt and that Downing Street had not 'sexed up' the case for the Iraq War (something that Kelly had secretly expressed fears about to BBC journalists, before his identity was outed by the Labour Government).
Only a tiny part of Hutton's 700-page report probed Kelly's death and the critical hours he was missing after taking an afternoon walk from his home in Southmoor.
Amazingly, the chief inspector of Thames Valley Police force, which conducted the search for Dr Kelly, was not called to give evidence. Nor was the Ministry Of Defence doctor who gave Kelly a clean bill of health during a rigorous medical check eight days before he died.
As a result of Hutton's failings, we still don't know the precise time and location of Dr Kelly's death - yet these basic facts are surely the most fundamental requirements of an inquiry into any violent or unexpected death.
Here, the Mail reveals the other vitally important questions that must now be answered . . . was he poisoned?
Friday, August 27, 2010
US Defense Department makes flu shots MANDATORY for teachers and students in Europe/ Stars and Stripes
Yes, this vaccine contains the swine flu antigen used last year and now, plus two other flu antigens. It is very similar to the vaccine banned for children in the UK and Australia, and similar to the vaccine banned last week in Finland and Sweden. But it will "protect the mission" and prevent parents from staying home to care for sick children. From Stars and Stripes:
For the first time, flu shots will be mandatory for students to attend Defense Department schools in Europe, education officials announced this week.
The immunization policy, mandated by U.S. European Command, covers both the seasonal and swine flu viruses and applies to teachers and employees at more than 80 Department of Defense Dependents Schools in Europe, as well as 30,000 students. Children older than 6 months enrolled in base daycare centers and daycare center workers throughout Europe also are affected by the move...
DODDS-Europe students already are required to get certain vaccinations for such viruses as polio, measles, mumps and rubella. Until now, however, the flu immunization, has been “highly encouraged,” but optional, a DODDS-Europe official said...
Requiring stateside family members associated with the military to get the vaccine when others in their community aren’t would likely cause “a tremendous amount of resistance” from teachers, students and parents, Kilpatrick said.
Mandatory inoculations may meet with less resistance overseas, where a military community tends to rely on the base for its health care, he said. In the States, even military families may have a civilian doctor “and parents get torn between medical communities...”
EUCOM is enforcing the policy because “our mission is to protect the health and safety of our beneficiaries,” Wyatt said.
When a child gets sick, that can take a parent who has to stay home away from the mission, he said.
“It’s about protecting the mission, as well...”
Swine flu vaccine safety probed by EMEA/ Telegraph
From the Telegraph:
The safety of a swine flu vaccine is to be investigated by European drugs regulators (EMEA, the European Medicines Agency) after it was linked to a rare condition that causes people to fall asleep suddenly.
The investigation has been prompted after health officials in Finland announced they were suspending the vaccination programme there following reports of narcolepsy in people who had received the jab.
So far there have been 27 reports of suspected narcolepsy in people across Europe who had previously been vaccinated with Pandemrix, the H1N1 swine flu vaccine made by GlaxoSmithKline.
Tuesday, August 24, 2010
Narcolepsy fears may halt swine flu vaccine: Finland and Sweden/ AFP
Agence France Presse reports that Finland and Sweden fear that narcolepsy in children could be a consequence of receiving GSK's Pandemrix flu vaccine. Pandemrix is last year's swine flu vaccine.
Its use has now been halted for all in Finland, despite Finland's health minister saying last week that the vaccination programme would continue:
Reports of narcolepsy in Sweden:
This season's flu vaccine
The vaccine linked to seizures in children in Australia, and halted for small children in the UK and Australia, is this year's flu vaccine. It contains the swine flu antigen plus other components. It is not yet known how the seizure problem relates to the swine flu component, nor whether this season's vaccine may cause narcolepsy.
However, CDC is crowing about the fact the vaccine is already on pharmacy shelves and CDC has recommended it for everyone over 6 months old. Outside a pandemic, flu is not expected to occur in the US until December at the earliest. CDC appears to want us vaccinated before information on the vaccine's risks emerges. CDC ordered 160 million doses made, expanded the target group of vaccinees to include the entire country, and now CDC needs to ensure those vaccines are injected, not rejected (like last year).
The larger point is not whether this vaccine causes narcolepsy. Different vaccines have caused different side effects, and usually a variety of side effects may occur in a minority of recipients after any vaccination.
The point is that if you don't look for them, you will miss the side effects. With 100 times the vaccinated population of Finland, why has the USA's CDC failed to identify any serious potential side effects? Why hasn't it held off vaccinations pending ongoing research in at least the US, UK, Australia, Finland and Sweden?
All public health programs need to have reliable data on hand before new vaccines or other public health strategies are used on a mass basis. Every intervention entails potential benefits, risks and costs. How significant is the expected benefit? Does it justify the cost? What are the risks, what is the incidence of side effects, and on balance, does the proposed intervention provide a significant net benefit commensurate with its cost? Until US public health policy makers get back to these basics, individuals will have to scrutinize new programs for themselves to determine whether they make sense.
Why are we funding CDC when instead of providing us useful information, CDC prefers to muddy the water in ways harmful to our health and pocketbook? CDC's 10 billion dollar budget could perhaps be better spent inspecting our food supply.
Its use has now been halted for all in Finland, despite Finland's health minister saying last week that the vaccination programme would continue:
Finland's National Institute for Health and Wefare recommended Tuesday halting the use of the Pandemrix swine flu vaccine until a probe into a possible link to narcolepsy among children is concluded.According to YLE, the head physician of the Finnish Medicines Agency, Kari Lankinen, says doctors failed to report their suspicions of swine flu vaccine side effects due to fears, for example, that they might have difficulty publishing in international journals. This demonstrates the insidious impact of political correctness in medicine these days.
"At the moment we are not having a (swine flu) epidemic, so there is no immediate need for vaccination," the agency said in a statement.
"Besides, major parts of the population are protected against the swine flu virus either through vaccination or or after having swine flu," it added.
Reports of narcolepsy in Sweden:
...concern children aged between 12-16 years who developed symptoms compatible with narcolepsy, a chronic sleeping disorder, that occurred one to two months after vaccination against the H1N1 pandemic.Narcolepsy is a serious condition: suddenly falling asleep without warning leads to many accidental deaths, especially in children and young adults. There is no known cure.
The (Swedish) Medical Products Agency said it was in contact with European Union member states for information on any similar reports in other countries.
This season's flu vaccine
The vaccine linked to seizures in children in Australia, and halted for small children in the UK and Australia, is this year's flu vaccine. It contains the swine flu antigen plus other components. It is not yet known how the seizure problem relates to the swine flu component, nor whether this season's vaccine may cause narcolepsy.
However, CDC is crowing about the fact the vaccine is already on pharmacy shelves and CDC has recommended it for everyone over 6 months old. Outside a pandemic, flu is not expected to occur in the US until December at the earliest. CDC appears to want us vaccinated before information on the vaccine's risks emerges. CDC ordered 160 million doses made, expanded the target group of vaccinees to include the entire country, and now CDC needs to ensure those vaccines are injected, not rejected (like last year).
The larger point is not whether this vaccine causes narcolepsy. Different vaccines have caused different side effects, and usually a variety of side effects may occur in a minority of recipients after any vaccination.
The point is that if you don't look for them, you will miss the side effects. With 100 times the vaccinated population of Finland, why has the USA's CDC failed to identify any serious potential side effects? Why hasn't it held off vaccinations pending ongoing research in at least the US, UK, Australia, Finland and Sweden?
All public health programs need to have reliable data on hand before new vaccines or other public health strategies are used on a mass basis. Every intervention entails potential benefits, risks and costs. How significant is the expected benefit? Does it justify the cost? What are the risks, what is the incidence of side effects, and on balance, does the proposed intervention provide a significant net benefit commensurate with its cost? Until US public health policy makers get back to these basics, individuals will have to scrutinize new programs for themselves to determine whether they make sense.
Why are we funding CDC when instead of providing us useful information, CDC prefers to muddy the water in ways harmful to our health and pocketbook? CDC's 10 billion dollar budget could perhaps be better spent inspecting our food supply.
Saturday, August 14, 2010
Top Tory (Michael Howard) backs Kelly inquest calls/ UK Press Association
From the UKPA:
Former Conservative leader Michael Howard has thrown his weight behind demands for a full inquest into the death of the government weapons expert Dr David Kelly.
His call came after a group of prominent experts described the official explanation for the scientist's death seven years ago as "extremely unlikely".
Lord Howard - who is now a Tory peer - said their intervention confirmed his belief that there should now be a proper inquest.
"In view of the growing number of relevant questions that have arisen and cast doubt on on the conclusions reached by Lord Hutton, I believe it would now be appropriate for a full inquest to be held," he told a national newspaper.
"Recent evidence by the first police officer on the scene, together with new statements by doctors raise serious questions which should be considered. This has been on my mind for quite a while and recent events have crystallised my view..."
Friday, August 13, 2010
Dr Kelly investigation 'was inadequate': Now NINE (new) top doctors demand inquest/ Times and Daily Mail
The 9 new experts wrote to ministers in an open letter to the London Times. Because the Times charges for access to its content, coverage in the Daily Mail is excerpted below:
Fresh doubts: There are calls for an inquest into the death of weapons inspector Dr David Kelly
Nine of the country’s leading doctors today dramatically question the verdict that Dr David Kelly killed himself by slitting his wrist.
The eminent medical experts say it is unlikely the weapons inspector could have bled to death in the way the authorities claim – raising fresh doubts that it was suicide.
In an open letter to ministers, they also urge the Government to conduct a full coroner’s inquest to re-examine key medical evidence surrounding the case.
The move heaps huge new pressure on the Coalition to reopen the investigation. The doctors are experts in the fields of forensic science, intensive care and law, and include Sir Barry Jackson, past president of the British Academy of Forensic Science.
Eight of the nine have never expressed their opinion on the Kelly affair publicly before. Their intervention shows the continuing deep disquiet among senior medics about the way Dr Kelly’s death was investigated by the Hutton Inquiry – dubbed a ‘whitewash’ by critics.
They join a growing chorus of experts who have made their concerns public.
Officially, Dr Kelly, 59, took his own life in woodland near his Oxfordshire home in July 2003 by cutting the ulnar artery in his wrist with a blunt pruning knife.
But a female colleague who served with him in Iraq, Mai Pederson, says a hand and arm injury had left him ‘too weak’ to cut his own wrist. Witnesses say there was little blood at the scene.
And experts have doubts that he lost sufficient blood to cause his death.
It also emerged after the Hutton Inquiry that no fingerprints were found on the knife Dr Kelly is alleged to have used, and that he was not wearing gloves when his body was found. The doctors voice their concerns in a letter to The Times newspaper.
It is backed by a second letter to Justice Secretary Kenneth Clarke, signed by Dr Michael Powers, QC. The letter questions the ‘adequacy of the investigation conducted by Lord Hutton’ and also calls on the Government to carry out an inquest...
Sunday, August 8, 2010
The cloud of doubt over Dr David Kelly must be lifted/ Sunday Mail
Thanks to the Mail for pursuing this important case. A more detailed piece the following day is here.
Troubling: Dr David Kelly
The death of Dr David Kelly still worries many thoughtful people. It is easy to see why. Dr Kelly’s concerns about the Government’s case for war in Iraq began a storm of controversy at a very inconvenient moment for Downing Street.
They stirred up the wrath of New Labour’s vengeful and ruthless propaganda machine.
These events led to a sort of show trial of a public servant with a fine reputation and a long record of diligence and competence – who, paradoxically, shared the Government’s concerns about Saddam Hussein.
But there was never any satisfactory conclusion to this process.
Dr Kelly never felt able to speak fully in his own defence. His close family, as is their right, have always preferred to stay silent about his feelings and about what pressures may have been placed upon him in his final days.
His violent death therefore deprives us of essential information about one of the most important political and military controversies of our age.
This would be troubling under any circumstances. But it is made far more perplexing by the cloud of doubt which surrounds the event itself. No proper inquest was ever held, itself an extraordinary circumstance.
And in the absence of a proper, open examination of his death under English law, that cloud of doubt grows and grows.
It may well be that all was exactly as we have been told, and that his death was a simple suicide.
Indeed, many of the circumstances make that a reasonable conclusion.
But with each independent account of the discovery of the scientist’s body, new questions are raised. The apparent absence of blood at the scene has always been a concern, since Lord Hutton’s report concluded that he had died from loss of blood.
Now, thanks to the recollections of Detective Constable Graham Coe, it is an even greater concern.
DC Coe is an experienced police officer who has been present at the aftermath of many deaths. The fact that he confirms the view of previous witnesses – that very little blood was visible at the scene – is a significant new development and strengthens the case for an inquest to be held.
The new Government should listen to that case, and so end the damaging uncertainty about how and why Dr Kelly came to die.
CDC Ignores Seizure Risk of Flu Vaccines/ CDC
Doctors in the UK and Australia have been instructed not to give flu vaccines this year to children under five years old. As reported by the Telegraph:
What did CDC do? This year, ignoring the risks, it has approved CSL's pediatric flu vaccine for children as young as six months. The vaccine has a different name than in the UK or Australia. But it is the same CSL vaccine that the Brits and Ozzies are worried about. CDC appears to have only one worry, and that is expanding vaccine sales. Its new flu vaccine guideline states,
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."
What did CDC do? This year, ignoring the risks, it has approved CSL's pediatric flu vaccine for children as young as six months. The vaccine has a different name than in the UK or Australia. But it is the same CSL vaccine that the Brits and Ozzies are worried about. CDC appears to have only one worry, and that is expanding vaccine sales. Its new flu vaccine guideline states,
"Previously approved inactivated influenza vaccines that were approved for expanded age indications in 2009 include Fluarix (GlaxoSmithKline), which is now approved for use in persons aged ≥3 years, and Afluria (CSL Biotherapies), which is now approved for use in persons aged ≥6 months."
Saturday, August 7, 2010
Tuesday, August 3, 2010
Officially sanctioned murder of US citizen supported by law banning legal challenge/ NY Times
What a Catch 22: Once the US Government designates someone as a terrorist, it becomes illegal to provide the designee with legal assistance challenging the terrorist designation!
The Obama administration announced to the world that it had the right to assassinate an American (Anwar al-Awlaki) citizen without any charges or trial last April.
According to the NY Times on April 6,
In today's NY Times:
The Obama administration announced to the world that it had the right to assassinate an American (Anwar al-Awlaki) citizen without any charges or trial last April.
According to the NY Times on April 6,
The Obama administration has taken the extraordinary step of authorizing the targeted killing of an American citizen, the radical Muslim cleric Anwar al-Awlaki, who is believed to have shifted from encouraging attacks on the United States to directly participating in them, intelligence and counterterrorism officials said Tuesday.Once you get on the terrorist list, it becomes a crime to offer a designated terrorist any assistance, including legal assistance to challenge the designation itself.
In today's NY Times:
“The same government that is seeking to kill Anwar al-Awlaki has prohibited attorneys from contesting the legality of the government’s decision to use lethal force against him,” says the complaint, which was jointly filed by the American Civil Liberties Union and the Center for Constitutional Rights...
Working without compensation, they began developing a lawsuit over whether the executive branch could lawfully carry out such a killing in the face of the Constitution’s protection against deprivation of life “without due process of law.”
But on July 16 — before the groups were ready to file such a lawsuit— the Treasury Department’s Office of Foreign Asset Control announced that it was applying the global terrorist designation to Mr. Awlaki. That step blocked Mr. Awlaki’s assets and made it a crime for Americans to engage in transactions with him or for his benefit without a license from the office...
“Targeting Americans for execution without any form of due process while at the same time obstructing lawyers’ ability to challenge that policy is fundamentally un-American,” said Anthony D. Romero, the executive director of the American Civil Liberties Union...
Vincent Warren, the executive director of the Center for Constitutional Rights, argued that international law did not permit a government to kill people far from combat zones, calling that assassination. And in the case of a United States citizen like Mr. Awlaki, he contended, such a policy also violates the Constitution’s Fifth Amendment — and is a dangerous precedent.Thank goodness for civil liberties lawyers, who have challenged this legal authorization of death squads and extra-judicial killings, combined with prevention of judicial review. (Is John Yoo back in government dreaming up these pseudo-legal arguments, or have the Dems found themselves a new pack of unethical, uneducated and "creative" lawyers?) This legal chicanery doesn't pass the [Constitutional] smell test.
“The governmental talking points around what is at stake does not make constitutional law,” Mr. Warren said. “We are trying to take this out of the realm of Sunday morning talk shows and put these issues before a court so the government can set forth the evidence.”
CDC is not recommending mandatory flu vaccinations for healthcare workers/Medscape
I have not been able to find the official announcement of this, but according to Medscape, the "Centers for Disease Control and Prevention (CDC) announced on June 22, 2010 that it would not endorse mandatory influenza vaccination for healthcare workers."
Monday, August 2, 2010
Unexpected hazards of factory-produced foods and other products/Washington Post
This summer, Kellogg recalled 28 million boxes of Froot Loops, Apple Jacks, Corn Pops and Honey Smacks. Dozens of consumers reported a strange taste and odor, and some complained of nausea and diarrhea. The company blamed elevated levels of a chemical in the packaging.
In a Washington Post article titled, US regulators lack data on health risks of most chemicals, we learn that federal agencies have absolutely no information available on the toxicity of the chemical suspected in the breakfast cereal reactions: 2-methylnapthalene. Ordinary napthalene is employed for its toxic effect: it is the main ingredient in mothballs, and is used to produce carbamate insecticides. The EPA states the following about plain napthalene,
In a Washington Post article titled, US regulators lack data on health risks of most chemicals, we learn that federal agencies have absolutely no information available on the toxicity of the chemical suspected in the breakfast cereal reactions: 2-methylnapthalene. Ordinary napthalene is employed for its toxic effect: it is the main ingredient in mothballs, and is used to produce carbamate insecticides. The EPA states the following about plain napthalene,
"Acute exposure of humans to naphthalene by inhalation, ingestion, and dermal contact is associated with hemolytic anemia, damage to the liver, and, in infants, neurological damage. Symptoms of acute exposure include headache, nausea, vomiting, diarrhea, malaise, confusion, anemia, jaundice, convulsions, and coma."According to the WaPo:
"It is really troubling that you've got this form of naphthalene that's produced in millions of pounds a year and we don't have some of the basic information about how toxic it is," said Erik Olson, an expert at the Pew Charitable Trusts...
If a manufacturer possesses data showing that a chemical harms health or the environment, it is required to turn over the findings to the EPA. Critics say that creates a disincentive for manufacturers to test their chemicals...
Because the FDA does not know anything about the toxicity of 2-methylnaphthalene, the agency set its limit based on what it knows about the toxic effects of similar chemicals, Michael Cheeseman (of the FDA's Office of Food Safety) said.
He added that the FDA does not know what caused the Kellogg contamination, how much 2-methylnaphthalene might have migrated into the cereals or if it was the only contaminant. The agency did not perform its own tests on the cereals...
"In this case, it had an odor and it had a taste, so it was detected," said David Andrews, a senior scientist at the Environmental Working Group, an advocacy organization. "But there are hundreds of other potential impurities that we can't smell and taste, chemicals that we know very little about and the government knows little about."
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:
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.
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).Furthermore, CDC plans to roll out the shots earlier than usual this flu season, during August. That makes little sense.
"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."
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.”...
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:
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.
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:
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.
... 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.From the Daily Mail:
“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.” ...
... In addition, it was recently disclosed that Dr Kelly’s death certificate was not properly completed.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.
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.’
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.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.
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.
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.
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
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.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.
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...
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: http://jacob.puliyel.com/#paper_213.
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.
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:
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).
...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?...Scroll down to the last (2 July 2010) letter on this BMJ page for the full text.
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].
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."
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:
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.
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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.
Tuesday, June 29, 2010
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 Sankai article is in Japanese.
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.
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.
Monday, June 28, 2010
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.
Tuesday, June 15, 2010
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..."
Sunday, June 13, 2010
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:
3. Part of WHO's justification for declaring swine flu a pandemic included the following:
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)
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.
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.
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