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Tuesday, August 4

U.S. government scrambles to revise pandemic planning in time for public school openings

Reading Spencer Hsu's report is like being transported to a mountain top after you've been struggling through thick jungle in the attempt to get your bearings.

It's all there, laid out in a few paragraphs: the confused thinking that dominates at the federal level and the equally confused thinking at the state levels of government, as officials try to determine how best to respond this fall to the swine flu outbreak.

Both levels of government make the same mistake. They assume they have the option of treating a pandemic virus as if were a test subject in a laboratory:
Strategy On Flu Under Revision
Federal Officials to Put Less Emphasis on School Closing

By Spencer S. Hsu
August 4, 2009
The Washington Post

The Obama administration is finalizing guidelines that would scale back when the federal government recommends closing schools in response to the swine flu pandemic, several people involved in the deliberations said Monday.

Such guidance would mark a change in the government's approach from this spring, when health officials suggested that schools shut down at the first sign of the H1N1 virus. They later relaxed that advice.

This fall, federal authorities would recommend closures only under "extenuating circumstances," such as if a campus has many children with underlying medical conditions, a senior U.S. health official involved in the talks said. The official added that discussions are continuing that and no final decision has been made.

Schools also might be advised to close if many students or staff members are already sick or otherwise absent, officials said.

"The framework is to try to keep schools open to the extent possible," the senior health official said, speaking on condition of anonymity because the White House has not completed its review of the issue.

School closings this past spring raised questions about whether they slow the spread of H1N1 and were worth the educational and economic cost. The federal government's decision could have a far-reaching effect on tens of millions of Americans, the economy and other countries wrestling with similar choices.

President Obama's top scientific advisers, Cabinet members and national security aides are racing to update the government's flu strategy before the school year begins this month, when infections are expected to surge -- particularly among young people.

Decisions on school closings will be made locally because the flu's severity varies geographically and because local and state governments have authority over school and public health matters, officials said. Local officials tend to rely on federal scientific advice, and federal guidance could change if the virus becomes more virulent or lethal, officials said.

John O. Brennan, the deputy national security adviser who chaired two Cabinet-level meetings in the White House last week to coordinate H1N1 planning, said the internal debate is intended to "think through all the angles" and avoid "knee-jerk" decisions, and he said it was too soon to predict the outcome.

"There will be circumstances where it makes sense to close schools, but what we are trying to do is refine" those instances, Brennan said.

U.S. authorities will release within days other "community-mitigation" measures, intended to help keep businesses operating, help hospitals avoid being overwhelmed and guide local authorities in deciding whether to cancel public events, officials said.

Experts say such decisions are timely because of the quickly approaching fall flu season.

The H1N1 virus does not appear to be more lethal than seasonal flu, but it might be two or three times as infectious and is expected to hit young, healthy people and schools especially hard.

[...]

Advocates of school closings say it is among the best options to slow a pandemic -- and thus reduce deaths and the strain on hospitals -- after developing a vaccine and antiviral drugs.

More than 700 schools nationwide, with nearly a half-million students, closed in late April and early May, following a pandemic plan that the U.S. Centers for Disease Control and Prevention published in early 2007.

On April 29, facing a spiraling H1N1 outbreak in Mexico, Obama urged U.S. schools with confirmed or suspected flu cases to strongly consider closing for as much as two weeks.

But the CDC stepped back May 4, noting that the disease did not appear as lethal as feared. The CDC said sick students and staff members should stay home for seven days. U.S. officials agreed to revisit the issue by fall.

Education officials said they felt bound to respect what federal officials were telling them, but they decried the effect of the closures, particularly the lost instruction time.

Federal officials proposed school closings after studying the outbreaks of severe acute respiratory syndrome (SARS) and avian flu in Asia earlier this decade, examining the 1918 and 1957 flu pandemics and using new computer models to consider the data.

But opponents of school closings said that the research relied on unrealistic assumptions and overlooked real-world factors.

H1N1/Swine Flu: DocJim reads the CDC's new manual on vaccination protocols so we don't have to

The physician who reported to Pundita readers last week on swine flu in England has waded through the CDC's Prevention and Control of Seasonal Influenza with Vaccines handbook, which was released on July 31, 2009. Here he summarizes the main points and adds his comments:

At 56 pages, including 10 pages of journal references, the handbook is quite a tome. Unfortunately, it is only marginally helpful:

• Injected influenza vaccine, 2009-2010 season is recommended for virtually everyone over 6 months of age: particularly for 6 months to 4 years of age and those above 65 years, plus those with chronic respiratory tract diseases (including asthma), diabetes, heart disease, immunologically active diseases and all women pregnant or likely to be within the next several months.

• Inhaled vaccine (Med-Immune) is for all of those between 4 and 60 years of age, but to be avoided by those in pregnancy or the listed diseases.

• There is some appeal scientifically for the inhaled, live virus vaccine over the killed, injected vaccine in terms of the immunity created. However, this is mostly theoretical at this time and there are concerns about live virus vaccines among those pregnant or with the listed chronic illnesses.

• Vaccines work with an efficiency between 50-90% in preventing clinical influenza and even with "wrong vaccine virus" there is some apparent usefulness.

• Influenza infections cause everything from symptoms of the common cold to death from overwhelming viral pneumonia, so numbers involving influenza are always subject to lots of interpretative arguments.

• Vaccination is especially important for health care providers and those who take care of young children or elderly or ill persons at home. It prevents cases of illness among those being helped, as well as among the helpers.

• Vaccination with the 2009-2010 vaccine will NOT contain the H1N1 Mexican swine flu strains. It is advised by the CDC that "everyone" as noted above should have this vaccine. (But it is likely that most of the influenza season of 2009-2010 in the USA will be from the H1N1 Mexican flu strains and that vaccine will probably be late in coming—maybe not until after the worst is over with the fall 2009 influenza.)

• Many people DO have some immunity to "new" influenza strains, but not enough immunity to keep from getting moderately ill with something "new." This creates great problems with statistics, but it is great for the person infected.

I believe this covers the most important aspects of this lengthy discussion.

I am suspicious of an early "flu season" in 2009 (September to early October) with most from the Mexiflu [2009 H1N1 swine flu].

The major rationale for going ahead and using the produced 2009-2010 vaccine is this concept for cross-over immunity, which won't prevent illness but may greatly reduce the severity.

On the other hand, they never push for non-pharmacological measures and this tome excludes discussion of those. Masks, for example are not "enough" to prevent infections, even if they greatly reduce infections.

My take on this year's flu vaccine: It will be about as useful as wearing a fresh mask every time you go out in public. Actually, the mask may be better -- but in the absence of absolutely preventing infection [the CDC] won't endorse its use.

I have not seen anything [from the CDC] discouraging the use of masks, as much as encouraging hand-washing/alcohol-hand-sanitizers and nothing much beyond that. Absolutely weird stance on these two segments of the flu story.

DocJim

DocJim -- Thanks for the summary. See my upcoming post today about a new CDC-funded study on the utility of face masks during an influenza epidemic. The study results throw light on the CDC's fence-sitting about masks.

Pundita

Monday, August 3

Why America's swine flu vaccination program will work even if it doesn't. BioMask and Biofriend QuickCloth, anyone?

Clint, my part-time assistant, forgot to publish a retraction regarding my post on a July 24 Reuters news report titled CDC stops swine flu death count at 300. By the late afternoon of the same day Reuters' health and science editor, Maggie Fox, had gotten hold of the report, re-written it under the more optimistic title, First defense against swine flu - seasonal vaccine, and deleted the erroneous mention about the swine flu death tally being halted.

What this boiled down to on my end is that until now there's a Pundita post floating around the internet that accuses the CDC of being the devil's handmaiden for suspending reporting on the swine flu death toll.

Yes, well, before I could fire him I'd first have to catch up with him between modeling assignments and besides the last assistant I fired, a Mark Steyn reject named Tiffany, packed chewed bubblegum under the G, E, R, K keys of my computer keyboard.

Just to make sure there's no misunderstanding here is the CDC's announcement about the change in their reporting on swine flu:
July 24, 2009 is the last day that CDC is providing individual confirmed and probable cases of novel H1N1 influenza. CDC will report the total number of hospitalizations and deaths each week, and continue to use its traditional surveillance systems to track the progress of the novel H1N1 flu outbreak. For more information about CDC’s novel H1N1 influenza surveillance system, see Questions & Answers About CDC's Novel H1N1 Influenza Surveillance.
These would be the same traditional surveillance systems that year after year have produced the same number, 36,000, for the annual death toll in the USA from seasonal influenza.

As to whether the CDC's new system of publishing a weekly grand total of deaths from swine flu is any more, or any less, helpful than the earlier state-by-state tally --

What the swine flu pandemic has turned up is that the entire system for collecting and reporting data on influenza infections and deaths from influenza is FUBAR. This situation is not only in the United States, it's in every country.

Seasonal influenza has long been treated by societies and the medical and public health establishments that serve them as an inevitable fact of life and of death, which took mostly old people.

Beyond developing a seasonal vaccine, it wasn't considered worth it to American society to treat yearly influenza as a dangerous epidemic. But now, with a highly unpredictable pandemic virus already bearing down on humanity, it's a little late in the day to scramble up a new system.

On July 14, just ten days before the CDC announced the change in their reporting, a news-making survey by London's Imperial College was published. It nailed down what everyone who'd been closely following swine flu already knew: the current system for estimating the proportion of people who will die if infected with swine flu is badly flawed. (1)

The estimates, which are derived from bad/outdated mathematical models and inadequate tracking methods, are already having serious consequences. That's because the statistics on swine flu deaths influence how medical establishments manage treatment for swine flu -- and how public health systems prepare vaccination strategies.

On July 16, two days after the Imperial College study was published, the World Health Organization officially washed their hands of the matter by announcing they would no longer publish data on the confirmed number of swine flu infections on a country-by-country basis.

This set off an uproar at Wikipedia, I might add. Since the earliest days of the swine flu outbreak volunteer contributors at the free encyclopedia have been doing the heavy lifting in keeping the global public informed about the daily number of confirmed/probable swine flu cases and the estimated death toll by individual country. After reasonably civil debate about how to handle WHO's roadblock, Wikipedia contributors rallied. They continued to publish what is still the best chart showing swine flu's global march.

WHO's announcement also set off an uproar in Pundita-land. Although WHO's long-winded, convoluted explanation for their decision didn't specifically state this, the change in their reporting method also meant they were no longer publishing the tally of cumulative deaths from swine flu by country.

As imperfect as the reporting is on swine flu deaths, the country breakdowns on the death toll are one indicator that taken with others provides the public with a rough idea of the pandemic's spread.

My reaction to WHO's announcement was to sputter in indignation, "Now watch! The CDC is going to follow suit!"

Well, in part, they did. Again, although the CDC will continue to provide a weekly death tally in the USA, it is now only a total figure; i.e., it does not show the breakdown by U.S. state of the death toll from swine flu.

Moreover, the CDC's weekly FluView, which features various interesting charts and graphs about the virus's activity in the USA, does not provide a by-state breakdown of the number of hospitalizations from swine flu; it only shows a total figure. And the 'activity' of the virus is reported only on a regional basis; i.e., various states grouped as regions.

So once again it has been left to Wikipedia volunteers to carry the battered standard of reporting to the general public on swine flu statistics. The highly readable chart at Wikipedia's 2009 flu pandemic in the United States by state page has U.S. state/territory categories for State-reported confirmed cases, State-reported probable cases, State-reported hospitalizations, and confirmed deaths.

Plus, Wikipedia provides a link to a map of every U.S. state, which shows exactly which regions in the state where the outbreak is occurring.

I am not sure how much further to pursue the issue of reporting on swine flu cases and deaths. In early May I applied medical reporter Kelly O'Meara's investigation about the number of U.S. deaths from seasonal flu to the swine flu situation and warned that the current method of estimating infections was badly flawed. During the following months I continued to sound the alarm.

By June 19 the Wall Street Journal had picked up on the question of accurate reporting on swine flu deaths. And on July 1 Barnaby Dawson, who was contributing to Wikipedia's section on data reporting and accuracy in reporting swine flu cases, wrote to congratulate me for zeroing in on the issue of estimating swine flu infections and deaths. (See comment section in the CDC hoodoo and swine flu lethality Pundita post.)

Shortly after, I saw that Wikipedia had added an explanation that estimating deaths from influenza was a complicated process and that the CDC's annual estimate of 36,000 deaths in the USA was misleading. Then came the Imperial College survey with its stark conclusions.

Yet none of this will make a dent in the public health establishment's entrenched view that once an epidemic is underway in a country it's a wrong use of resources to attempt to keep track of individual cases of swine flu.

This idée fixe, which represents a sweeping generalization carried to the point of absurdity, has done much to obscure the true impact of swine flu. Early on in the outbreak it served as the rationale for WHO, CDC and other major public health authorities to encourage health departments to abandon testing for all but the most serious swine flu cases.

The critical flaw in the rationale can be intuited by noting that the American state of Wisconsin (population 5,627,967) has five municipal laboratories. This explains their proud assertion that the state's comparatively large number of confirmed swine flu cases in the early weeks of the outbreak was due to their state's superior testing for the virus.

On the other hand, New York State (population 19,490,297) has only two municipal laboratories. One of the labs serves New York City, the most populous city in the union and one of the world's mega-cities (estimated at 8.3 million in 2007). The other lab serves the rest of the state.

(As to why one of the world's largest cities, located in the world's lone superpower nation, has only one municipal lab -- you'd have direct that question to the city's Mayor Michael Bloomberg or Thomas Frieden, who was the city's health commissioner from 2002 until June 2009 when he took over as head of the CDC.)

China's laboratories have not been overwhelmed by swine flu specimens; the same holds true for many countries where swine flu infections are still few. Even the CDC's own map of the activity of swine flu in different U.S. states shows a wide variation in the severity of the outbreak in the USA.

In other words some regions of the world and the USA can produce a far more accurate picture of the number of swine flu infections than others; how this data changes over the course of the pandemic would more throw light on the speed and spread of the pandemic.

So a more helpful approach would be for authorities to encourage testing of all suspected swine flu cases to the extent possible then setting up categories for countries/states that couldn't keep up with testing, and those that could.

There are other strategies that could be deployed to give a more accurate picture of how a unique virus is progressing in its pandemic phase. For example, in the USA the "311" city government phone number, or numbers that serve the same purpose, could be used by hospitals and doctors to report suspected swine flu cases in regions where the labs are overwhelmed. While of course not a perfect method this would be better than nothing.

The 311 number is for city residents to report on a municipal problem -- uncollected garbage, electrical problems, and so on. In a 2005 essay, Dial 311, I highlighted a TIME magazine report on how officials in Chicago belatedly discovered the import of several 311 calls, from different parts of the city, which complained about dead birds.

The calls, had they been studied as a pattern, would have given health officials early warning of an outbreak of West Nile Virus in Chicago.

If the pattern had been noted earlier human lives could have been saved. Yet the discovery of how 311 could predict an infectious disease outbreak was a watershed; despite this, the great power of 311 for discerning disease patterns has not been utilized in the swine flu outbreak.

I write all the above in the manner of a symbolic gesture, knowing I'm wasting my breath. That's because societies stand and fall by their totems, their fixed ideas.

There's a simple explanation as to why a technology such as 311 hasn't been fine-tuned to keep track of suspected swine flu infections, and why other reasonably inexpensive steps haven't been taken to obtain better data on swine flu.

The explanation is that vaccines have been so successful so much of the time against threat from infectious diseases that governments and the societies they serve have placed their bet on the vaccine solution -- even in the face of a pandemic virus that displays unique properties.

That's why, with the striking exception of China, societies have made only the most haphazard or token attempts at deploying NPIs ('non-pharmacological interventions') against swine flu. And that's why WHO and the CDC didn't urge nations and states to devise creative strategies for collecting data on swine flu.

That's also why the CDC and their parent agency, Health and Human Services, could assign a low priority to the GAO recommendations on swine flu readiness. Here's a report you didn't find splashed all over the nightly TV news last week:
U.S. unprepared for second wave of swine flu, report finds

By Carrie Wells
McClatchy Newspapers
Posted on Wed, Jul. 29, 2009 05:04 PM

The federal government isn't prepared for a potential outbreak of swine flu this fall, a Government Accountability Office report released to Congress concluded Wednesday.

Furthermore, said the GAO, Congress' nonpartisan investigative arm, federal agencies haven't addressed nearly half of the 24 recommendations it made last month.

William Coor, the deputy secretary of health and human services, disputed the findings.

"Given the speed at which the virus has spread we felt our work and coordination has been outstanding," he said. However, Jane Holl Lute, the deputy secretary of homeland security, acknowledged that, "We still have work to do."

The GAO agreed, saying that if a severe outbreak struck:

- Federal, state and local governments would have trouble coordinating with one another.

- The number of beds and medical supplies would be insufficient.

- Plans to protect federal workers aren't adequate.

Health officials worldwide acknowledge that the virus has reached pandemic proportions and could strike more severely in the fall. In the U.S., more than 43,000 people have contracted the virus, and so far, 302 have died.

Rep. Bill Pascrell, D-N.J., called the report "startling" after it was presented to the House Homeland Security Committee Wednesday.

The committee voted unanimously to urge the federal departments to respond to the GAO's recommendations within three months.

"Based on our survey, progress seems to be limited," said Bernice Steinhardt, the GAO's director of strategic issues. The rosy outlook of the agencies could be because they still haven't tested what they'd do in a severe outbreak, she added.

Lute listed the steps that her agency has taken to prepare, including reaching out to Native American tribal governments and drafting a response plan.

Coor also defended his department's actions.

Coor added that HHS and the Federal Emergency Management Agency in the next few weeks will give directions to state and local governments on how to deal with a big outbreak.

Swine flu, or H1N1, emerged in April in the U.S., and by June, the World Health Organization said it had grown to pandemic proportions. The WHO said it has killed at least 816 people worldwide. The Southern Hemisphere is now in its regular flu season, and swine flu there has been particularly deadly.

Coor said a vaccine won't be ready for several more months, after trials are finished. He also said federal and state governments have stockpiled 75 million to 100 million antiviral treatments, a number he called "sufficient." [Don't bank on that, Mr Coor.]

National Treasury Employees Union President Colleen Kelley told the committee the federal government communicated poorly with federal workers earlier this year.

For example, federal employees were forbidden from wearing face masks to avoid getting the virus unless they were within six feet of a person who seemed likely to have swine flu.

The committee's chairman, Rep. Bennie Thompson, D-Miss., wasn't happy with the report.

"Given this country's recent experience with disasters, it is hard to believe that there are those who underestimate the importance of plans and drills," he said. "Our children are taught in school what to do in a fire drill. They are not taught to wait until a fire starts, yell instructions and hope everyone makes it to the exit."
Yes, well, drills are necessary only because there's no vaccine yet against fire and hurricane.

Mr Coor might be wrong about the length of time before a vaccine is ready for distribution in the USA. On the same day he spoke to the panel I saw a report from a vaccine company that the swine flu virus was suddenly growing faster than it had been, which the company representative said would speed up vaccine production.

As to how the government is going to pull together a more comprehensive plan at this late hour -- if a mass vaccination program is Plan A, I suspect Plan B was always that the U.S. military would come up with a plan.

With the opening of U.S. public schools only a few weeks away, and perhaps noting that Plan A might not go off without a hitch, the military has finally submitted a proposal to start planning.

It's my wild hope that the planning will include the Department of Defense calling China's Ministry or Health and asking, 'Just exactly how did you set up your entry ports intervention and quarantine program?'

The details would be handy to know in the event swine flu comes roaring back to the Northern Hemisphere in a more lethal and/or Tamiflu-resistant mutation. It would be so nice to cut into its exponential spread by catching as many infected people as possible at major points of entry to the USA but there I go again, asking for the moon.

Aside to American readers who live in terror of being herded into FEMA quarantine camps: you might have some reason for terror now. Not to lecture but if the government had instituted quarantines at the beginning, quarantinees in the USA would have been able to loll around for a week badgering their minders to add more variety to the dinner menu and more cable channels on the TV in their room.

The quarantine experience might be a different story, later on. So if you think you live in terror of FEMA camps, just imagine what the Obama administration and Democratic leaders in Congress are going through. The last thing the Democrats need right now is TV footage of thousands of hysterical Americans being marched into the Houston Astrodome. Don't cackle, Pundita; it's unseemly.

Look on the bright side: either America's swine flu vaccination program, "the largest vaccine effort the world has ever seen" will work or it won't. And even if our traditional way of doing things doesn't work this time around that doesn't mean it failed. If this is a little hard to follow I explained it all quite clearly, if I do say so myself, once upon a time in 2005:

"Pundita:
The hallmark of science is not its ability to explain but its ability to predict (I mean prediction BEFORE something actually happens rather than the more common claiming to have predicted something AFTER it happens). How do so many people (particularly in foreign relations) whose predictions have been so poor hold onto their jobs?
Dave Schuler
The Glittering Eye"

Dear Dave:
Your remarks are very broad. But if you're referring to people whose job is to make predictions for the US government, you are misinformed. Such people are invariably right in their predictions.

I know that news will come as a shock so allow me to play your guide for a trip through Washington-land. Before we scamper down the rabbit hole let us hop back in time, so that the lay of the land in Washington, DC is more readily seen:

Say your job is to be the high priest, a job passed down from your uncle. Your major duty is to ensure a good harvest each year, which you accomplish by hurling 10 virgins off a cliff. It worked for your uncle, it worked for his uncle, and for 20 years it worked for you until the 21st harvest came a cropper.

Naturally you are hauled before the king, who demands an explanation about why the crops failed because his subjects are massed outside the gates and demanding an explanation.

Now tell Pundita what you would say. "I have no idea" would be the wrong answer if you want to hang onto your position not to mention your life. You have to come up with an explanation for the presumed anomaly.

Put another way, you haven't the foggiest idea why hurling virgins off a cliff worked to bring a good harvest and why it stopped working. And if you're a very smart high priest, you might have a hunch that one event has nothing to do with the other. However, with your life on the line, it would be the wrong time to take up lab-bench science.

To spare you the brain sweat I will quote from page 632 of the 11,465 page How to Survive your Job as High Priest: Book of Answers which provides an array of explanations for earlier science's failure to accurately predict events.
The crop failed because:

Blame it on the assistant
a) The virgins were too young.
b) The virgins were too old.
c) They hadn't been properly tested to ascertain that they were actually virgins.

(Note: Any answer from this menu calls for the immediate execution of the assistant.)

Blame it on the harvest god
a) The god is now demanding a doubling in the number of sacrificed virgins.
b) The god is in a bad mood.
c) The god was busy fighting a war with other gods and forgot about the harvest.

Blame it on the king's subjects
a) The people have not been showing proper respect to the harvest god.
b) The people have been fighting with each other, which angered the god.
c) The people became lazy and deceitful and didn't share enough harvest with the king's bounty collectors.

(Note: float this one only if the king is in good standing with the military.)

Different combinations of the above explanations should be enough to get you through another few years, until whatever's wrong with the harvest rights itself. If all else fails:

Blame it on the king
a) The king has started thinking he's more powerful than the harvest god.

CAUTION: Try this one only after consultation with courtiers and generals assures you that the king is next off the cliff anyhow. [...]
To put all this another way: people have spent eons coming up with creative excuses for why their way of doing things doesn't always work; by now CYA is embedded in humanity's DNA.

Not that I want to annoy the CDC's totem but there is a way to hedge the bet: a middle ground between the sure thing and the sure thing that's sure to work the next time. Filligent's BioMask and QuickCloth, anyone?

RBO blog's Swine Flu Reader has links to all my posts on swine flu since April.


1) New Scientist: Swine flu death rate estimates 'flawed;' Andy Coghlan; July 14, 2009

Tuesday, July 28

How does BioMask defend against H1N1 swine flu? First let's make sure we're talking about the genuine BioMask. (Update 3:50 PM ET-VICTORY AT GOOGLE!)

Here is what the Filligent BioMask™ looks like:

On Saturday, when American radio show host John Batchelor inteviewed Filligent co-founder and CEO Melissa Mowbray-d'Arbela about her company's BioMask™, he spelled out the word "Filligent" for his audience.

And at the end of the interview he told the audience to "Google BioMask" for more information about the mask.

Here we come to a snag -- or, in the immortal words of Dorothy Parker (and Jay Currie), "One damn thing leads to another."

If you google "BioMask," "biomask," or "Biomask" you'll see, near the top of the first Web page under "Images" for the BioMask™, a photograph of a man wearing a bio-chemical warfare/accident mask. That is not the BioMask™.

Yet to the left of the man's image are two photographs of genuine BioMask™ packages. And to his right is a diagram of the genuine BioMask™ construction.

In other words, the unwary could easily assume that the bio-chem mask is the BioMask™. This is most unfortunate because no one in his right mind would wear the bio-chem mask unless he was trying to survive a bio-chem incident or scare the hell out of someone.

I am not a Google wizard so I have no idea how to fix this problem and after searching unsuccessfully for an email address where I could send my complaint to Google, I gave up the idea of asking Google for help.

If anyone knows how to fix the problem; i.e., get the photograph of the bio-chem mask removed from the line-up of BioMask™ products and substitute a photograph of a genuine BioMask™ (note the name is trademarked) at the BioMask, Biomask, and biomask Google Web pages, please fix it.

There is possibly a workaround to the problem: this morning I noticed that my post of yesterday about the BioMask™ has appeared near the top of the second page of Google's Web page for "BioMask." The accompanying photograph, the same as the one above, does show the BioMask™.

So if you wouldn't mind, could you visit the second Google Web page (links provided above) and click on the link to my post that has the BioMask™ photo attached?

Perhaps if enough people do this, it will move the link to my post and the accompanying photograph of the BioMask™ onto the first Google Web page. And, I hope, even move the photograph right underneath or above the one of the gentleman wearing the bio-chem mask.

If this works, at least Google readers can see at a glance what the real BioMask™ looks like, and not assume they have to frighten the living daylights out of people to be suitably masked against a flu bug.

Thank you for your help in this matter

This not to say I don't think the well-prepared person shouldn't have a bio-chem mask handy. But right now we are in the midst of a pandemic and for that I think the BioMask™ is the best facial mask for protection against the 2009 swine flu.

And, as you can see, the mask is the most attractive one available for the purpose. It's also the most 'breathable' and comfortable. It can be worn all day and even during heavy exercise.

It's also easy to put on; it has adjustable ear loops and a double curved shape that expands to fit closely to most faces. It comes in two sizes so it can fit not only an adult face but also a child's.

The mask is also safety-certified and non-irritating to skin.

As for the technology that goes into the mask it does everything but bake bread:
In 2008, Filligent developed a revolutionary technology which traps & kills viruses and bacteria on contact. This molecular technology can be applied to substrates such as rayon and cotton textile fibre.

BioFriend™ captures microbes by mimicking the sites on human cells to which they normally attach, then, destroys them by disrupting their surfaces (viruses) and cell walls (bacteria). BioFriend™ kills the full universe of germs including those that cause Influenza A, Bird Flu, common colds, measles, pneumonia, SARS, tuberculosis, and MRSA.

By targeting only the dangerous elements, BioFriend’s intelligent filtration technology optimizes breathability and comfort.

With BioFriend's ability to kill a broad range of microbes, while applied to various substrates, the technology naturally lends itself to wide application across consumer products. Not only does BioFriend™ contain and protect against infection, but it also keeps items of everyday personal use, prone to bacterial and viral contamination, safe and clean.
Check out Filligent's products page for information about other anti-pathogenic items they sell.

And give a listen to John Batchelor's interview with Melissa Mowbray-d'Arbela. The podcast is at this link, July 25, Hour 2, the second interview.

RBO blog's Swine Flu Reader has links to all my posts on swine flu since April, and which have been crossposted there with illustrations provided by RBO.

Monday, July 27

H1N1 Swine Flu: More on Filligent's pandemic-fighting BioMask and other BioFriend products


Filligent co-founder and CEO Melissa Mowbray-d'Arbela's interview with John Batchelor was great. The podcast for the interview (Saturday, July 26, 10:20 PM ET) will be posted at John's website sometime today. She told John that the BioMask™ (at right) is available for sale in every country but the USA. She also said that Filligent is waiting on FDA approval before the BioMask can be sold in the USA.

Over the weekend Freedom Fairy sent me a link to an online medical supply company that will start selling the BioMask on September 1st. You can probably put in an order now. I didn't check to see if they're selling other Filligent products made from the same BioFriend™ material as the BioMask. I did note that the site takes all major credit cards.

The mask and other BioFriend products, including the fabulous BioFriend pathogen-zapping dry hand cloth (the "QuickCloth") and the BioFriend QuickPatch, are being sold at Filligent Europe, which accepts payments via Pay Pal. Freedom Fairy said there are several other online medical supply outlets that are selling the mask or will be, and which can be found through a search engine.

Regarding the patches, I'd originally thought of slapping them on kids' clothes so they could just wipe their hand across the patch to remove viruses and bacteria. But another use would be to stick the patches on your desk at work and right outside the office lunchroom.

I don't know how big the patches are but you could always stick a few together to make a larger surface. People could wipe their hands on the patch before they entered the lunchroom. The patches might not last as long with several people using them (the QuickCloth is good for a month of personal use) but heck, they're not expensive and even if they have to be changed every day outside the lunchroom it'd be worth it during a pandemic.

Many people won't take the time to properly wash their hands even if they're inclined to wash them. If you only wash for 10 seconds, you might as well not wash at all if your purpose is to neutralize pathogens. So the more I think about the patches the more places I can think to stick them.

And I am not sure how long it takes alcohol-based gel sanitizers to work. I can't find the link but recently I read that alcohol has to be on a surface a few minutes to sanitize it. Don't quote me on that but if it's true, and the sanitizer you've used hasn't worked by the time you touch your eyes, nose, or mouth or any surface, that's defeating the purpose if you're carrying a virus. The BioFriend technology used in the masks, cloths, etc. kills bacteria and viruses virtually instantly.

Sunday, July 26

Carbon tariff proposal: That's the ticket! Start a global trade war during a pandemic and deep global recession!

At the rate things are going in the USA Donald Duck could run for Congress next year as a Republican and win. His entire platform could consist of, 'Quack I'm not a Democrat quack quack' and he'd still be a shoo-in. At the rate things are going in the EU I give the WTO less than a year before it quacks up:
ARE, Sweden (Reuters) - Germany called a French idea to slap "carbon tariffs" on products from countries that are not trying to cut greenhouse gases a form of "eco-imperialism" and a direct violation of WTO rules.

The issue of greenhouse tariffs has met bitter opposition from developing countries such as China and India, who count on the developed world to buy their exports as they build their economies in the face of the worst financial crisis in decades.

Matthias Machnig, Germany's State Secretary for the Environment, told a news briefing on Friday that a French push for Europe to impose carbon tariffs on imports from countries that flout rules on carbon emissions would send the wrong signal to the international community.

"There are two problems -- the WTO (World Trade Organization), and the signal would be that this is a new form of eco-imperialism," Machnig said.

"We are closing our markets for their products, and I don't think this is a very helpful signal for the international negotiations."

European environment and energy ministers are meeting in Sweden to try to come up with a single vision of how the 27-member bloc will fight global warming, ahead of a major environment summit in Copenhagen.

The first phase of the 1997 Kyoto Protocol on cutting greenhouse gas emissions is set to expire in 2012. Final negotiations on a successor climate change pact will take place in the Danish capital at the end of the year.

U.S. LEGISLATION

The U.S. House of Representatives has already passed legislation that contains carbon tariffs. It would allow the United States to impose duties on imports of carbon-intensive goods such as steel, cement, paper and glass from countries that have not taken steps to reduce their own emissions.

Some say such tariffs could be a backup plan for Europe, should United Nations members fail to reach a deal in Copenhagen.

But Swedish Environment Minister Andreas Carlgren, whose country holds the rotating European Union presidency, said member states currently had no "plan B" beyond landing a deal in Copenhagen. He said there was as yet no official proposal on the table from the French regarding carbon tariffs. "We are absolutely against each try to make use of green protectionism," Carlgren told Reuters. "There should be no threat of borders, of walls or barriers for imports from developing countries."

French President Nicolas Sarkozy's office said last month such taxes could help create a "level playing field" for European companies competing with international firms from countries that have not put a price on carbon emissions.

EU Energy Commissioner Andris Piebalgs has said member states should keep the French proposal in mind, but also worries how such tariffs could be viewed by other countries.

China said earlier this month carbon tariffs would violate the rules of the WTO and the spirit of the Kyoto Protocol.

Such tariffs would represent a radical shift for the WTO, whose goal is reducing barriers to trade. However, the WTO says it is possible to impose import tariffs if such taxes are also imposed on a country's own industry to ensure a level playing field.

However, Europe could see some progress on domestic carbon taxes on a national level within the 27-member bloc. Sweden's finance minister, Anders Borg, plans to raise the issue at the next finance ministers' meeting, Industry Minister Maud Olofsson told a press briefing.

(Additional reporting by Johan Ahlander and Julien Toyer; Editing by Mark Trevelyan)

Saturday, July 25

Our Man in Lancashire reports on Swine Flu Front in England

Before he left for a ten-day stay in England I asked physician and Pundita reader "DocJim" to tell me, on his return to the USA, his impressions of how the British were coping with swine flu. Here is his report, just received:

Having boarded a flight in Manchester, UK, yesterday morning, I took one of the offered newspapers. There was ONE mention of swine flu in this Thursday evening paper: on the sports page. A local football (soccer) team's coach was voicing concerns about what swine flu could do to his team if several members became infected.

This was Manchester, after all, not London. The London papers continually had front page scare stories about swine flu each day for the week my wife and I spent in Lancashire.

BBC had daily long interviews and panels on swine flu. On Thursday evening in an airport hotel we could see SkyNews and Granada TV in addition to BBC. They were all talking swine flu.

A bookshop clerk in Lancaster was asked on Monday about concerns about swine flu? "None," she replied, and she went on to say, "It's all about a coverup."

Of what? "The economy." She had spent the weekend in London and says it was business as usual to her eyes and she was amused by several young Asian men wearing masks. "They were students just off the plane, no doubt."

It would be fair to say that the UK epidemic of swine flu slowed last week, because the schools ended there term for summer holiday. By the end of the week, some commentators were reporting that locales with huge increases in caseloads the week earlier were now showing lesser growth, while some newer areas were accelerating in cases.

The Brown government is blamed for both hyping the swine flu story and doing too little about it. There has been mass confusion. Government politicians like Sir Liam Donaldson have reversed positions sporadically and people in general are feeling let down by the NHS.

The newest UK plan is to offer Tamiflu packages at a nearby pharmacy to anyone who calls the national "hotline" and passes the verbal test of symptoms. "Experts" set up the dichotomous key that begins with "Do you have high fever?"

Unfortunately, I could not find the definition of high fever. Presumably, all Brits know exactly what that means.

The call center personnel were folks out of work who had received a six hour training session.

As it opened on Thursday, the website was jammed by hits and the call center had immediate busy signals. One enterprising person at SkyNews called with carefully predetermined symptoms of strep throat and was offered Tamiflu at a local pharmacy.

One other horror story was of a teenage girl given Tamiflu for 5 days with no improvement and her family took her to the Accident and Emergency Ward where she was hospitalized with meningitis.

The London newspapers were now carrying a story about the millions paid to one UK vaccine manufacturer of swine flu vaccine. That company had shown a profit for the current quarter while they had received the government millions for the swine flu vaccine doses which they are in the process of producing.

As a physician, I can understand that free Tamiflu and an excited populace had overwhelmed the nation's GPs. Early last week they were reeling from phone calls and emails from patients. Many simply wanted to have a supply of Tamiflu on hand, in case they became ill.

No one knows with real certainty why there is a surge of influenza in the colder months of the year. One study suggests the virus is more infective when the nose breathes in colder air. They have some data to 'prove' that theory but I remain a sceptic. The UK experience in the London vicinity schools -- which were rarely closed with large cases of flu and where case rates fell off the week after schools closed -- seems instructive.

Two stories about UK school groups traveling to foreign countries made the local news during the week: in China the group was quarantined for a week when two children had symptoms of flu on arrival and in the second case a group traveling to France was sent home with masks on their faces, amid taunts by French people seeing them in the airport. It didn't do much positively for Anglo-French relations, but that has never bothered the French.

DocJim

Is there a Gatesgate connected with Obama pal Professor Henry Gates?

We interrupt this blog on swine flu to bring you breaking news, or at least breaking observations, by sharp-eyed Dan Riehl at Riehl World View.

Friday, July 24

H1N1 Swine Flu: Filligent CEO Melissa Mowbray-d’Arbela on John Batchelor Show to talk about Filligent's pandemic-fighting BioMask

Melissa (picture below) needs no introduction to readers of this blog. I'm happy to announce that she'll be a guest on John's radio show on Saturday, July 25 at 10:20 PM Eastern Time.

The Saturday show broadcasts from New York City's megawatt 77 WABC-AM, which can be picked up across a wide region in the Eastern USA (and even in parts of Canada), and which can be heard online nationally and globally.

A podcast of the interview will be available the next day at the show's website.

Although John's website hasn't announced this yet, 630 WMAL-AM out of Washington, DC, which airs a portion of John's Sunday show, has picked up the last three hours of the new four-hour Saturday Batchelor show.

The WMAL Saturday broadcast starts at 10:00 PM Eastern Time, so Melissa's interview will be included.

WMAL can be heard online, although I'm not sure of the internet range outside the Greater Washington, DC area, which includes parts of Virginia and Maryland.

To the best of my knowledge the Saturday show has not been picked up by the California stations broadcasting the Sunday show although I hope that will change. See John's website for more information on the show and for the Saturday and Sunday schedules, which are generally available by Saturday.

For those who are new to the swine flu party or don't know about Melissa and the BioMask™:

Melissa Mowbray-d'Arbela, an Australian based in Hong Kong, is the CEO and co-founder of Filligent, Ltd. From her interview in POWER magazine and her biographical sketch at Filligent she seems quite an extraordinary person -- a cross between an entrepreneur, humanitarian and innovator.

Here is the BioMask™:
And here is what it looks like being worn:

Science 2.0, April 27, 2009:
"According to pandemic experts an effective face mask like the germ-killing BioMask could reduce the number of cases from one million to just six in the first months of a pandemic."
But there's no other mask like BioMask™.

It's made from a material that represents a biotechnology advance.

The mask is lightweight, comfortable, highly 'breathable,' perfectly fitting, moisture and mold resistant, inexpensive, safe for humans, non-irritating to skin, and as attractive as a face mask can be. And, most importantly, it's an assassin:

Typical face masks (including standard surgical masks and N95s) do not kill airborne pathogens. They are based on a passive mechanical filtration design only. Thus, microbes on or inside the mask can stay alive for many hours, greatly increasing the likelihood of cross-contamination.

The BioMask™ traps and kills bacteria and viruses within seconds of their landing on the outer layer of the mask's surface. That solves the problem for people, especially children, who fiddle with their face masks all the time they're wearing them, thereby transferring germs to their hands.

It's that kind of problem that's caused health experts to view surgical masks, even the N95 respirator-type ones, as little use in an epidemic.

Another problem is that regular surgical masks are ill-fitting; they tend to gap at the sides, which means they don't contain sprays from sneezing and coughing. The BioMask™ is designed to be a good fit.

What's the kill rate?
As part of the CE testing process, the BioMask™ was sprayed with live aerosolized Influenza A virus equivalent to 50 times the amount contained in a normal sneeze. (The Mexican swine flu is a strain of the Influenza A virus.) More than 99.9% of the viruses were killed after less than one minute. Similar tests were conducted on other key pathogens, with similar results.
What about safety?
When the BioMask™ was tested in terms of all the major routes of exposure, oral and dermal, it showed no harmful effects on humans. The BioMask™ has been tested for dermal biocompatibility following internationally recognized standards set out in ISO10933: Biological Evaluation of Medical Devices. Tests were conducted to evaluate cytotoxicity to cells, skin irritation on contact, and skin sensitization after repeated contact. No cytotoxicity, irritation or incidence of sensitization was observed.
You can read more about the BioMask™ and the technology behind it at Science 2.0 or the Filligent website. (Filligent is a portmanteau of "filter" and "intelligence.")

For those who're wondering -- yes, the BioMask™ germ-killing techonology, named BioFriend™, has other applications, which include an amazing 'dry' hand-washing cloth and a patch.

See the Filligent website for more data on the BioMask™, the implications of which are mind-boggling. If the mask was widely used at the start of an outbreak of an airborne infectious disease for which no vaccine is available, it would greatly slow the rate of infection. In combination with other NPIs ("non-pharmacological interventions"), it would ward off a pandemic even before a vaccine was ready for use.

Then why, given the mask's availability since April, is Hong Kong the only place that the mask is selling retail? (It went on sale July 7 at Asia's leading drugstore chain, Watsons.)

I don't know; there's no obstacle from the Filligent end that I can see. According to their literature, the mask is "flat-packed and can be surge manufactured. We are working with retailers and humanitarian organizations to get the BioMask™ and our other anti-infective products out to people as soon as possible."

I do know there hasn't been much publicity about the mask in the USA. To my knowledge no media outlet, beyond a few blogs and scientific and medical web sites, has reported on it.

That situation will change on Saturday's John Batchelor show. Stay tuned.

RBO blog's Swine Flu Reader has links to all my posts on swine flu since April, and which have been crossposted there with illustrations provided by RBO.

H1N1 Swine Flu: Filligent's BioMask goes on sale in Europe (REVISED 6:00 PM ET)

Reference my July 21 post Filligent's BioMask can stop a pandemic. It's now for sale in Hong Kong. So when can you buy it at your local drugstore?

Without going into gory detail or flinging around blame, I'll just note that the original version of this post contained information that reflected, shall we say, a breakdown in communication regarding some information about the Filligent Europe company.

However, the Filligent Europe website still shows that they are taking orders for the Filligent BioMask™ and other pandemic-fighting products made with Filligent's patented BioFriend™ technology. (To the best of my knowledge they will only be able to fill orders in Europe.)

Now to rescue what I can of the original version of this post.

I want to start by showing you what the Filligent BioMask™ looks like because there are lots of different pictures of "biomasks" on the internet, and one of them looks like something out of a horror movie. Here is the BioMask™:


Don't be fooled by imitations; there is only one BioMask™, which as you can see is a trademarked name.

Visit the Filligent Europe web site for information on ordering the BioMask/BioFriend products. And here's the link to the Filligent site.

I note from their website that Filligent Europe is set up to accept small orders for the mask in addition to large ones. The company is also selling the "QuickCloth." How cool is this?
Tuck the BioFriend™ QuickCloth into your purse or pocket and keep your hands clean without soap, gel or water! Dry-sanitize your or your child’s) hands by rubbing them with the QuickCloth. BioFriend’s revolutionary, patented technology traps and kills bacteria and viruses on contact:

> Lifts off and kills harmful germs
> DRY sanitization
> Reusable
> Convenient
> Save water! Save paper!
> Great for kids
> Self-sanitizing

BioFriend™ traps microbes by mimicking the sites on human cells to which they normally attach, then,destroys them by disrupting their surfaces (viruses) and cell walls (bacteria).

Kills germs including the superbug MRSA plus those that cause gastroenteritis, herpes, Influenza A, Bird Flu, common colds, measles, SARS and tuberculosis.

Hand wash only. Replace after one month of active use.
Filligent Europe is offering other products based on the BioFriend technology. The QuickPatch looks interesting, especially for small children, who tend to lose things like cloths. I guess you just slap a couple patches on their arms or clothing when they go out, and they can rub their hands on the patch to clean them. But I love the thought of that hand cloth because I'm really tired of using the gel sanitizers.

Meanwhile:
July 23 (Bloomberg)

[...] 3M’s safety unit benefited from a “tremendous sequential surge” in demand for the masks last quarter because of the spread of H1N1, also known as swine flu, Chief Financial Officer Patrick Campbell said today on a conference call with analysts and investors. The investment will boost mask capacity worldwide by 10 percent."

“We are going to have some sustainable growth that comes from H1N1,” Chief Executive Officer George Buckley said on the call. Demand for the protection is “huge,” he said.

Masks to protect against the H1N1 influenza virus are on back-order through 2009, Buckley said. 3M and Kimberly-Clark Corp. are among the few manufacturers that make respiratory masks sophisticated enough to ward off swine flu, exacerbating shortages. Only masks rated N95 or above, which can filter at least 95 percent of airborne particles, are effective at blocking the virus, according to the U.S. Department of Health and Human Services.
I'm happy for 3M's bottom line but the problem is that the masks they make for commercial use, including masks rated N95 or above, are not efficient at fighting a pandemic virus (i.e., a highly infectious influenza virus). It's the same for all the other masks, with the exception of the BioMask™. From the Filligent website: [...]
Typical face masks (including standard surgical masks and N95s) do not kill airborne pathogens. They are based on a passive mechanical filtration design only. Thus, microbes on or inside the mask can stay alive for many hours, greatly increasing the likelihood of cross-contamination. When compared to the tight-fitting N95 face mask, the BioMask™ is far superior in terms of efficacy, comfort and breathability.[...]
See the website for lots more information on why the mask is special -- and right on time to fight a pandemic.Meanwhile:
(July 24 Wall Street Journal) - Global health officials are scrambling to try to prevent the spread of the H1N1 swine flu virus, with U.S. officials moving Thursday with a recommendation that the Food and Drug Administration approve or license a vaccine.

[...]

In the U.S., a federal advisory panel said the FDA should move ahead to approve or license the new H1N1 vaccine without waiting to receive data from clinical trials to test its safety and efficacy. The government and vaccine makers plan to start human studies of the H1N1 vaccine in the U.S. in the coming weeks, but the first-look data from those studies won't be given to the FDA until September.

Each year the FDA approves seasonal vaccines based on strain changes without new human studies. The agency does test the vaccines for potency and also monitors vaccine safety on a continuous basis.

"I think this is an entirely appropriate way of proceeding and in the public health's best interest considering that schools will be opening in a month," said John Modlin, the panel chair and a professor of pediatrics at Dartmouth-Hitchcock Medical Center.

Health officials health officials said Thursday they have purchased enough bulk ingredients to produce 195 million doses of swine flu vaccine, and expect to make up to 100 million doses available in October, even though the vaccine is proving difficult to manufacture. Federal officials told the FDA panel Thursday that four companies making H1N1 vaccines -- Sanofi Aventis, Novartis AG, GlaxoSmithKline PLC and CSL Ltd. -- said the viruses used to make the active ingredient are producing yields of just 30% of what's typically seen with seasonal vaccines.

The new H1N1 shots would be for a vaccination campaign that potentially would be targeted first at school-age children, who along with young adults have been hit hard by the new flu strain. A Centers for Disease Control and Prevention vaccine advisory panel will meet next week to make recommendations about such a vaccination campaign.

Anthony Fiore, of the CDC's influenza division, said the agency is anticipating that two doses of an H1N1 vaccine would be needed. That limits the number of people at high risk for flu who would be able to get the shots in the early fall, although health officials are hoping that clinical study data will show that one dose is enough to protect some people. It will take until March to obtain enough doses for the entire U.S. population of just over 300 million people, officials predicted. [...]
RBO blog's Swine Flu Reader has links to all my posts on swine flu since April, and which have been crossposted there with illustrations provided by RBO.

Tuesday, July 21

Filligent's BioMask can stop a pandemic. It's now for sale in Hong Kong. So when can you buy it at your local drugstore? (REVISED 7/22)

Since May 23, when the U.S. government announced they'd contracted with three drug companies to make enough swine flu vaccine "to immunize at least 20 million people in key positions in health care, national security and emergency services," there has been one glitch after another in getting vaccine manufacturing up to speed.

Last week an article by AP's medical reporter Mike Stobbe provided insight into one reason for the delay: before gearing up for swine flu production, the companies needed the U.S. government to indemnify them against lawsuits that might be filed because of side effects or death from the swine flu vaccine. Last month Department of Health and Human Services Secretary Kathleen Sebelius signed the document, which also indemnifies federal officials. And because people wouldn't be able to sue the companies for wrongful death or injury the government had to set up a fund to provide compensation.

One can't blame the vaccine makers, who don't need to make influenza vaccines to turn a profit, for dragging their feet until they had some assurance they wouldn't be sued out of existence. The USA is a litigious society. But all this has cost precious time in the face of a pandemic.

All that says nothing about other problems involved with swine flu vaccine development and distribution. Yesterday another ace medical reporter who's been closely tracking swine flu issues, Helen Branswell at the Canadian Press, took the bit between her teeth and gave the lay reader a summary of the most vexing problems that would be comprehensible to the layperson. The Effect Measure blog expanded on Banswell's report, again in a language that's accessible to the general reader. I'll let those two sources bring you up to speed on the vaccine problems.

But the issues that have arisen with the vaccine and vaccination logistics point up the folly in assuming, this early in the virus' life, that a vaccine would be the magic bullet against a pandemic.

As the assumption has crumpled the inadequacies of U.S. pandemic planning have become increasingly evident. One big problem is that the planning relied too much on pharmacological interventions (anti-virals and vaccines) and too little on NPIs (non-pharmacological interventions).

Examples of NPIs are all those plodding things China's government has insisted on doing; e.g., quarantine, rigorous 'social distancing' measures, careful monitoring of arriving international air passengers for a temperature, etc.

On Sunday Effect Measure took up the gloomy theme of pandemic unreadiness in the USA, which I've been pounding away at for months on this blog.

I don't agree with the author's speculation that today's pandemic won't rend the social fabric in the USA any more than it did during the 1918 pandemic, but I found the rest of the observations worthy of note.

As early as mid-May USA Today also took up the unreadiness theme with a report bluntly headlined, USA ill-equipped for a swine flu pandemic, experts fear.

Curiously, or perhaps not, much of the article is given over to officials congratulating themselves on how well they've done to prepare for pandemic but as the article winds on it's clear that the readiness is relative; there was no readiness at the time of the SARS outbreak, so yes relatively speaking there has been improvement in pandemic readiness. I'm afraid that's not saying much in the face of the real McCoy. It's like having only half a tornado cellar built when the funnel cloud appears on the horizon.

So here we are today, with not much more than Tamiflu and Sesame Street's instructions on how to sneeze and wash our hands properly, as our bulwark against a pandemic's onslaught. And with the start of the school year six weeks away -- five weeks, in some regions of the USA.

The really bad news is that swine flu didn't perform to the experts' expectations and leave the Northern Hemisphere at the end of the annual influenza season. We may not see the full implications of this until schools re-open in September. The vaccination program for public school students is always at the start of the school year, before flu season begins.

So how this situation is going to be impacted, if this year schools are hit with a flu epidemic as soon as they open, is probably another question public health and school officials are wrestling with right now.

With all the above in mind, the rest of this writing is to tell you about a remarkable invention called the BioMask™, which is made by a company called Filligent. My description of the mask is based on the one posted at Science Blogging 2.0, which draws on Filligent's literature about the mask.


Science 2.0, April 27, 2009:
"According to pandemic experts an effective face mask like the germ-killing BioMask could reduce the number of cases from one million to just six in the first months of a pandemic."
But there's no other mask like BioMask™ (right), which is made with a material that represents a biotechnology advance.

The mask is lightweight, comfortable, highly 'breathable,' perfectly fitting, moisture and mold resistant, inexpensive, safe for humans, non-irritating to skin, and as attractive as a face mask can be.

Oh and I forgot to mention it's also a smart assassin:

Typical face masks (including standard surgical masks and N95s) do not kill airborne pathogens. They are based on a passive mechanical filtration design only. Thus, microbes on or inside the mask can stay alive for many hours, greatly increasing the likelihood of cross-contamination.

The BioMask™ traps and kills bacteria and viruses within seconds of their landing on the outer layer of the mask's surface. That solves the problem for people, especially children, who fiddle with their face masks all the time they're wearing them, thereby transferring germs to their hands.

It's that kind of problem that's caused health experts to view surgical masks, even the N95 respirator-type ones, as little use in an epidemic.

Another problem is that regular surgical masks are ill-fitting; they tend to gap at the sides, which means they don't contain sprays from sneezing and coughing. The BioMask™ is designed to be a good fit.

What's the kill rate?
As part of the CE testing process, the BioMask™ was sprayed with live aerosolized Influenza A virus equivalent to 50 times the amount contained in a normal sneeze. (The Mexican swine flu is a strain of the Influenza A virus.) More than 99.9% of the viruses were killed after less than one minute. Similar tests were conducted on other key pathogens, with similar results.
What about safety?
When the BioMask™ was tested in terms of all the major routes of exposure, oral and dermal, it showed no harmful effects on humans. The BioMask™ has been tested for dermal biocompatibility following internationally recognized standards set out in ISO10933: Biological Evaluation of Medical Devices. Tests were conducted to evaluate cytotoxicity to cells, skin irritation on contact, and skin sensitization after repeated contact. No cytotoxicity, irritation or incidence of sensitization was observed.
You can read more about the BioMask™ and the technology behind it at Science 2.0 or the Filligent website. (Filligent is a portmanteau of "filter" and "intelligence.")

For those who're wondering -- yes, the BioMask™ germ-killing material, named BioFriend™, has other applications, which include disposable facial tissues.

The implications of the filtration mask are so vast that I'm still having a hard time wrapping my mind around them. If the mask was widely used at the start of an outbreak of an airborne infectious disease for which no vaccine is available, it would greatly slow the rate of infection. In combination with other NPIs, it would ward off a pandemic even before a vaccine was developed.

Then why, given the mask's availability since April, isn't it sold at retail outlets in every country including here in the USA?

I don't know; there's no obstacle from the Filligent end that I can see. According to their literature, the mask is "flat-packed and can be surge manufactured. We are working with retailers and humanitarian organizations to get the BioMask™ and our other anti-infective products out to people as soon as possible."

I do know there hasn't been much publicity about the mask in the USA. To my knowledge no media outlet, beyond a few blogs and scientific and medical web sites has reported on it.

I learned about the mask from following a link at the Snowy Owl medicine man blog at Daily Kos that led to a link at the Chen Qi pandemic news blog.

(This shows how speedily news is disseminated in the digital age when the mainstream media ignore or miss a story: same speed as in the carrier-pigeon age.)

A June 12 press release from Filligent mentioned there was interest in the mask in Australia. But right now the only place on the planet you can buy the BioMask™ retail is Hong Kong, where it became available July 7 at Asia's leading drugstore chain, Watsons.

As to when BioMask™ will be available on China's Mainland -- I haven't seen a discussion of that but money says by September at latest. The mask is also being given away:
Hong Kong’s biggest travel agency, Hong Thai, will be providing the BioMask™, on a complimentary basis, to all air travelers through the end of August. Up until now, the CE-certified, specialist mask has only been available to medical and healthcare professionals.

The launch and availability of the BioMask™ in consumer retailers and service providers is significant because, as CEO Melissa Mowbray-d’Arbela says, “The BioMask™ is the first ‘intelligent’ face mask. You don’t have to be a health care worker or medical professional to use it correctly. Instead, the mask is very easy to put on, wear and dispose of properly. Thus, it’s one of the best forms of protection for ordinary people and their children during this year’s swine flu crisis.”
I'd say so too.

Mowbray-d'Arbela (left), an Australian based in Hong Kong, is a co-founder of Filligent. From her interview in POWER magazine and her biographical sketch at Filligent she seems quite an extraordinary person -- a cross between an entrepreneur, humanitarian and innovator.

Mowbray-d’Arbela, and indeed the entire Filligent enterprise, also display the odd trait of putting the horse before the cart, as in:

While we're waiting for government to get everyone to stop smoking, why not make a better cigarette filter, so smokers don't have to inhale 4,000 chemicals every time they take a puff? While we're waiting for government to end air pollution, why not take personal means to protect oneself from the worst effects of pollution? While we're waiting for government to distribute the perfectly-matched flu vaccine -- you get the picture.

To put it all a different way: If enough schoolchildren could be coaxed to wear the mask, at least until the swine flu vaccination program is completed, that would put a crimp in swine flu's style and save many lives this winter -- as well as saving many parents their jobs. A Harvard survey in June pointed up that many Americans are concerned about the impact of swine flu on finances:
[...] Many parents were worried about outbreak-caused closures of schools or day care centers, with 43 percent saying they would lose pay or have money problems if they had to stay home a week or more because they were sick or had to care for someone.

About 25 percent said they probably would lose their job or business, which was especially concerning to black and Hispanic parents. More than 40 percent in those racial groups feared losing a job or business, compared with 14 percent of whites. [...]
And I don't think it would take much coaxing to get children to wear the mask at school. My first sight of the BioMask™ photo above made me think of a ninja. It's a cool-looking mask, not like the weird, clunky N95 or the sloppy-looking, wrinkled affairs worn now by people trying to protect themselves against swine flu.

And children are practical; I think they'd understand the need for the mask at school, and that they'd rather enjoy the thought of wearing a contraption that zaps germs.

So I'd urge my fellow Americans to encourage your local pharmacy, and school and public health officials, to stock up on the BioMask™.

And if the mask requires FDA approval before it can be used in the USA, I’d hope Congress, DHHS, and Homeland would encourage the agency to fast-track approval.

RBO blog's Swine Flu Reader has links to all my posts on swine flu since April, and which have been crossposted there with illustrations provided by RBO.

Monday, July 20

H1N1 Swine Flu: Pandemonium Weekend in United Kingdom

Pandemonium Update from July 20 edition, The (U.K.) Sun:
Meanwhile today it was revealed that security teams will be drafted in to guard supplies of swine flu drug Tamiflu. The ring of steel will be put up outside distribution centres to stop thefts and protect staff from desperate patients. More than 100 centres will be set up at pharmacies and clinics across London. Police have been involved in drawing up plans for the centres whose locations have been kept secret.
Reference my comments below about the Tamiflu honor system. Sir Liam really, really needs to re-think the phone-in system.
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NO SMIRKING WARNING: So how's your government's pandemic planning coming along?

Friday Pandemonium Edition

Sir Liam Donaldson, the U.K.'s chief medical officer, got the weekend off to a roaring start by ordering the country's National Health Service to prepare for 65,000 deaths in the U.K. in the next few months with a death toll at 350/day at the pandemic's peak this winter.

Is the British government blowing the situation out of proportion? About two weeks ago, when Health Secretary Andy Burnham was quoting mathematical projections that 40 Britons could die every day from swine flu, maybe the answer would have been yes.

At that time the government was trying to turn on a dime: go from assuring the public that swine flu was nothing to worry about to preparing the public for what might have to be a mandatory vaccination program.

Today, studying the outbreak pattern in England, I'm afraid I've had cause to remember my May warning that highly populated island nations are a sitting duck during a pandemic.

So while gossip has it that Sir Liam tends to be an alarmist about infectious disease outbreaks, frankly if I were in his position right now I'd also come down on the side of abundant caution:
Sir Liam revealed that there are 652 swine flu victims in hospital in England, 53 in intensive care.

In the last week alone, there have been 55,000 new cases of flu-type illness - more than twice the figure for last week.

All areas, except Yorkshire, are experiencing 'exceptional' numbers of cases and there are ten local hot-spots, mostly in London.

It means the swine flu outbreak, still only in its early stages, is already worse than last year's winter flu, which was itself the biggest outbreak for nine years.

[...]

Sir Liam said: 'What we have unveiled are a range of planning scenarios. It does not mean that we think that will come to pass.'

In one planning assumption the death rate would be 0.1 per cent of those who catch swine flu.

In the worst-case scenario it would be 0.35 per cent. Assuming 30 per cent of the population get the disease, there could be up to 65,000 deaths.

This compares with 6,000 from normal seasonal flu and 21,000 in the last flu epidemic in the winter of 1999/2000.

A death toll of 65,000 would be double the number who died during the pandemics of 1957/8 and 1968/9.

It would make the outbreak the worst since the Spanish flu of 1918/19, which killed hundreds of thousands in the UK.

John Oxford, virologist at Barts Hospital in London, said last night: 'It's fair for the NHS to put these assumptions on the table, but I would predict that the number of deaths will be much, much lower - at the bottom end of their scale.

'There is no reason for people to get into a flap over this. I've seen the preparations and I'd rather be in England than anywhere else in the world.'

Dr Steve Field, chairman of the Royal College of General Practitioners, said last night: 'People should not panic. The virus seems to be very infectious, but in the vast majority of cases it is causing only mild symptoms. There is no cause for alarm at the moment.'
It's those "hot spots" or cluster outbreaks, as they're also called, which could be reflecting exponential spread of the infections.

The British government won't bite the bullet and institute quarantines and other strong NPIs (non-pharmacological interventions) to tamp down the clusters. So they've thrown together a stop-gap measure in the attempt to placate reality:
To relieve what he called the 'enormous' pressure on the NHS, Sir Liam announced that a phone and internet service would start from the end of next week, allowing people to get Tamiflu without seeing their GP.

The National Flu Pandemic Service will operate from a series of call centres manned by 2,000 staff from agencies, most of whom are expected to be students and temps.

People will be able to ring a single number - to be released shortly - if they believe they have swine flu.

Operators will ask a range of questions and, if the answers suggest the person may have swine flu, they can prescribe Tamiflu.

At present, people who ring NHS Direct still have to call their GP to get the drug.

The Department of Health confirmed that call centre staff would not be medically qualified, but said they would receive training on symptoms and there would be medically-trained people on site.

From next week, patients will also be able to get Tamiflu prescriptions over the internet.

Those prescribed Tamiflu through the new service will be told to stay at home and nominate a 'flu friend' to pick up the drugs from local depots.

The new flu line will initially be available only in England. The aim is to take the pressure off family doctors, who will be dealing with the most serious cases.

Critics fear the scheme will give the 'worried well' access to Tamiflu even if they do not need it - depleting the NHS stockpile.

But Sir Liam said he was trusting people not to abuse it.

Ministers have been stung by accusations they were too slow to respond to previous crises such as foot and mouth.

They are determined to be seen to be making all possible preparations for swine flu. [...]
I have a bridge in Brooklyn I'd like to sell Sir Liam

The Worried Well are not the biggest problem. It won't take Pakistani dope dealers in the U.K. even four minutes to figure how to rip off the phone-in system and sell Tamiflu on black markets in poor nations. That's because the black-market distribution networks are already in place, stretching from their end of the AF/PAK heroin pipeline throughout Asia and the Middle East.

And it won't just be Pakistanis; every crook in the U.K. who's plugged into a 'black' or deviant globalized business network will have gang members, friends and relatives snuffling to the phone-in line that they're deathly ill, and describing their swine flu symptoms.

I give the phone-in system three weeks before the locusts pick the national stockpile of Tamiflu clean.

Sir Liam sticks his foot in his mouth again, and a lesson from the Google office panic in India

The phone-in scheme and Sir Liam's talk about an honor system ignore the realities for people in poorer countries, who are already scrambling to obtain Tamiflu. Supplies are very tight in many countries.

I interject that I'm not going to sit here day after day and give the same warning to Sir Liam. But within hours of my admonishment that he shouldn't say in public that the British were at the front of the swine-flu vaccine queue, his comments set off an international row. WHO's Margaret Chan accused the Western nations of hogging all the vaccine.

Just a few days ago an Indian hospital ran of out Tamiflu when panicked Google employees who'd been exposed to swine flu at the office descended to demand Tamiflu.

There weren't enough capsules to go around and with no means to quickly test every employee for the disease, the doctors were only giving out enough Tamiflu for prophylactic doses, and only for a couple days -- not long enough to stave off swine flu.

And the lower prophylactic dose is an engraved invitation to swine flu to mutate into another Tamiflu-resistant strain if the person is already infected, beep this is a recording.

Say, why not try a pandemic-fighting strategy that works?

And that is another problem with the phone-in system described by Sir Liam. Tamiflu is most effective if administered within six hours of onset of symptoms; after 48 hours of the infection the medication is no longer effective.

There was a news report over the weekend that thermometers had been cleaned off the store shelves in the U.K. I assume, I hope, the situation will be quickly rectified. But if people dose themselves at the wrong time with the Tamiflu they've obtained from the phone-in system they're not only wasting Tamiflu, they're also risking not having the stuff on hand if they really do become ill with the virus.

So I would advise that the ministers spend a little less time trying put on a show of activity, and invest more time in thinking.

Stop and consider: Mexico's President Felipe Calderón broke the back of the swine flu outbreak in Mexico City by declaring a five-day government holiday in the city and asking city businesses to close shop during the period.

This fact is so well known that I won't even take time to find a news link to support my statement. But a few weeks ago, at the swine flu summit in Cancun, Calderón was practically pinned with a medal for his quick thinking and bold action to fight swine flu in Mexico City.

The holiday, which he created by extending the regular weekend and Cinco de Mayo holiday by two extra days, rendered Mexico City a ghost town for five days. And it cost Mexico millions USD if not billions. But by gum it stopped the spread of the virus in one of the world's most populous cities.

This being the Novel 2009 Swine Flu Virus we're talking about, of course the little anarchist only laid low. Then it popped up again -- in two rural areas of Mexico, if recall.

I haven't had time to keep up on the outbreak in Mexico so I don't know how Calderón responded to that theater of war opening up. And probably the virus eventually popped up again in Mexico City.

But the wholesale 'social distancing' created by the holiday threw a lot of sand in the virus's gears. And slowing down the rate of infections is the name of the game for pandemic fighters beep this is a recording.

As for what a swine flu holiday would cost the British economy -- how much money are they going to be losing if only part of Sir Liam's worst-case scenario comes about?

Shut down the cluster outbreaks in London by declaring a holiday, at least in London. And once you isolate the outbreaks, that's where you plug in the Tamiflu.

And you're really going to slow the virus if you combine a five-seven day holiday with quarantine of cluster outbreaks, although I might be dreaming if I think the Labor government would follow advice to quarantine.

However, they've just got to bash the infection outbreaks back over the line long enough for a vaccine to be administered and take effect. Yet surely the government realizes at this point that their vaccination program is running into snags that could delay it by several weeks or even months. So don't base planning on an assumption the vaccination program will be in high gear by the end of August.

Back to the drawing board?

On Friday Novartis pharmaceutical whined that the swine flu virus virus they're growing to make a vaccine doesn’t yield much of the antigen:
Lab workers are harvesting one dose or less of the component they need from each egg in which the virus is grown, said Eric Althoff, a spokesman for the Swiss drugmaker. That’s between a third and half of the typical yield for a seasonal flu vaccine, he said.

The low yield may slow production of a pandemic vaccine because it means drug makers like Novartis, Baxter International Inc., Sanofi-Aventis SA and GlaxoSmithKline Plc can extract less of the protective ingredient from each egg. Baxter’s Chief Executive Officer Robert Parkinson and a spokesman for Sanofi also said yesterday the amount of swine flu virus growing in each egg is lower than for seasonal flu.
What happened to Novartis' super-duper cutting edge cell technology, which made culturing the vaccine in eggs unnecessary?

Just last month they'd announced they'd finished the first batch of vaccine ahead of schedule:
"The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak," said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.

"This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners. I believe it highlights our reputation as a leader in influenza vaccine research, development and production."
Like a fool I believed them and touted the breakthrough in a Pundita post. Moving right along:

Pandemic Pandemonium Weekend, Saturday Edition

Swine flu vaccine fears as first jabs available before full details of clinical safety trials are known
The first swine flu vaccine will be given to the public before full clinical data about its safety is available, it has been revealed.

The first samples of the pandemic vaccine will arrive at the end of this month and a decision whether to approve it would then be taken within five days.

But a spokesman for the European Medicines Agency has confirmed that no clinical trial data from human volunteers on the vaccines will be available until September at the earliest.

Last night the Department of Health insisted that the vaccine would be safe and warned that any suggestion otherwise would create unnecessary panic.[...]
Don't panic, you say?

Then came the bombshells:
[I]n Britain it was being reported that pregnant women are to be given advice to avoid travelling on trains and stay away from crowds.

Parents would also be advised to keep babies away from crowds and to limit the movements of their other children to stop them bringing the virus home.

The advice was based on a joint statement from the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives.

However, last night the Department of Health said it was not issuing any such warnings, despite predicting last week that thousands more fatalities were expected after the UK death toll reached 29.

In another development, the National Childbirth Trust was accused of scaremongering by the Royal College of General Practitioners after reportedly advising women to consider postponing becoming pregnant.
Sunday Edition, from the same bombshells report as above:
Doctors want guards to protect wards

Doctors want guards on the doors of hospitals and intensive care units in case the families of swine flu victims become violent if they are refused treatment.

There is already a chronic shortage of intensive-care beds, particularly for children, across the country. But doctors anticipate that demand could soon exceed capacity as the number of serious cases of swine flu rises.

Bruce Taylor of the Intensive Care Society - which represents ICU staff - said: ‘Violence from patients’ families is on a list of things that staff might have to worry about as this pandemic progresses.

'We may be forced, in terrible situations, to limit patients who we’ll admit and families will understandably be annoyed. There may be circumstances where security staff are necessary.’

A spokeswoman for the Department of Health said: ‘Decisions on whether this is necessary should be taken locally.

‘It is part of pandemic planning to prepare for worst-case scenarios but it is important to say that this is not a prediction.’
"Annoyed" was perhaps a poor choice of words but to continue, from the same report:
One in five workers may soon be off sick

As many as one in five people could be off work because of swine flu within a fortnight.

Experts yesterday predicted up to 20 per cent of the 29 million workforce could take time off because they are ill or have to care for relatives who have been struck down.

The under-30s are most likely to be affected because figures show they are the ones taking most time off with flu-like symptoms.

The Health Department said last week that one person in eight could be off work with swine flu in a worst-case scenario. However, absence management specialist FirstCare, which provides its data to the Government, says the situation is escalating more rapidly than anticipated.

It says in the past few days the number off sick with flu-like symptoms, coughs and colds has leapt from around one in 630 to one in 200. That rises to one in 150 when taking into account staff forced to look after sick relatives.

If the rate of absence continues at the same pace, one in five will be staying at home by the start of August.

The Federation of Small Businesses said such a scenario would be ‘devastating’ and could cost the economy around £1.2 billion a day.
Now wouldn't it have been simpler to do as the Chinese did and stage the first line of defense at U.K. international airports? Not that I enjoy pounding away, day after day, at the same point. But what WHO termed China's "resource intensive" swine-flu fighting method is looking more cost effective by the hour, isn't it?

That was the weekend.

The Monday morning hangover

Burnham to give swine flu update

(UKPA - late Sunday night) - Health Secretary Andy Burnham is to update MPs on swine flu following a weekend of confusing signals over advice for high-risk groups.

In a statement to the Commons before Parliament rises for the summer recess, he is expected to provide the latest information on the outbreak ahead of the launch of a new flu hotline at the end of the week.

It follows attempts by health officials to allay fears over the impact of the illness on pregnant women and young children over the weekend.[...]
See RBO blog's Swine Flu Reader for all my previous posts on swine flu, which are also published at RBO. The recent posts provide additional information about the swine flu outbreak in the U.K. and the government's approach to handling it.