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.

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