Tag Archives: WHO

AI (artificial intelligence) for Good Global Summit from May 15 – 17, 2018 in Geneva, Switzerland: details and an interview with Frederic Werner

With all the talk about artificial intelligence (AI), a lot more attention seems to be paid to apocalyptic scenarios: loss of jobs, financial hardship, loss of personal agency and privacy, and more with all of these impacts being described as global. Still, there are some folks who are considering and working on ‘AI for good’.

If you’d asked me, the International Telecommunications Union (ITU) would not have been my first guess (my choice would have been United Nations Educational, Scientific and Cultural Organization [UNESCO]) as an agency likely to host the 2018 AI for Good Global Summit. But, it turns out the ITU is a UN (United Nations agency) and, according to its Wikipedia entry, it’s an intergovernmental public-private partnership, which may explain the nature of the participants in the upcoming summit.

The news

First, there’s a May 4, 2018 ITU media advisory (received via email or you can find the full media advisory here) about the upcoming summit,

Artificial Intelligence (AI) is now widely identified as being able to address the greatest challenges facing humanity – supporting innovation in fields ranging from crisis management and healthcare to smart cities and communications networking.

The second annual ‘AI for Good Global Summit’ will take place 15-17 May [2018] in Geneva, and seeks to leverage AI to accelerate progress towards the United Nations’ Sustainable Development Goals and ultimately benefit humanity.

WHAT: Global event to advance ‘AI for Good’ with the participation of internationally recognized AI experts. The programme will include interactive high-level panels, while ‘AI Breakthrough Teams’ will propose AI strategies able to create impact in the near term, guided by an expert audience of mentors representing government, industry, academia and civil society – through interactive sessions. The summit will connect AI innovators with public and private-sector decision-makers, building collaboration to take promising strategies forward.

A special demo & exhibit track will feature innovative applications of AI designed to: protect women from sexual violence, avoid infant crib deaths, end child abuse, predict oral cancer, and improve mental health treatments for depression – as well as interactive robots including: Alice, a Dutch invention designed to support the aged; iCub, an open-source robot; and Sophia, the humanoid AI robot.

WHEN: 15-17 May 2018, beginning daily at 9 AM

WHERE: ITU Headquarters, 2 Rue de Varembé, Geneva, Switzerland (Please note: entrance to ITU is now limited for all visitors to the Montbrillant building entrance only on rue Varembé).

WHO: Confirmed participants to date include expert representatives from: Association for Computing Machinery, Bill and Melinda Gates Foundation, Cambridge University, Carnegie Mellon, Chan Zuckerberg Initiative, Consumer Trade Association, Facebook, Fraunhofer, Google, Harvard University, IBM Watson, IEEE, Intellectual Ventures, ITU, Microsoft, Massachusetts Institute of Technology (MIT), Partnership on AI, Planet Labs, Shenzhen Open Innovation Lab, University of California at Berkeley, University of Tokyo, XPRIZE Foundation, Yale University – and the participation of “Sophia” the humanoid robot and “iCub” the EU open source robotcub.

The interview

Frederic Werner, Senior Communications Officer at the International Telecommunication Union and** one of the organizers of the AI for Good Global Summit 2018 kindly took the time to speak to me and provide a few more details about the upcoming event.

Werner noted that the 2018 event grew out of a much smaller 2017 ‘workshop’ and first of its kind, about beneficial AI which this year has ballooned in size to 91 countries (about 15 participants are expected from Canada), 32 UN agencies, and substantive representation from the private sector. The 2017 event featured Dr. Yoshua Bengio of the University of Montreal  (Université de Montréal) was a featured speaker.

“This year, we’re focused on action-oriented projects that will help us reach our Sustainable Development Goals (SDGs) by 2030. We’re looking at near-term practical AI applications,” says Werner. “We’re matchmaking problem-owners and solution-owners.”

Academics, industry professionals, government officials, and representatives from UN agencies are gathering  to work on four tracks/themes:

In advance of this meeting, the group launched an AI repository (an action item from the 2017 meeting) on April 25, 2018 inviting people to list their AI projects (from the ITU’s April 25, 2018? AI repository news announcement),

ITU has just launched an AI Repository where anyone working in the field of artificial intelligence (AI) can contribute key information about how to leverage AI to help solve humanity’s greatest challenges.

This is the only global repository that identifies AI-related projects, research initiatives, think-tanks and organizations that aim to accelerate progress on the 17 United Nations’ Sustainable Development Goals (SDGs).

To submit a project, just press ‘Submit’ on the AI Repository site and fill in the online questionnaire, providing all relevant details of your project. You will also be asked to map your project to the relevant World Summit on the Information Society (WSIS) action lines and the SDGs. Approved projects will be officially registered in the repository database.

Benefits of participation on the AI Repository include:

WSIS Prizes recognize individuals, governments, civil society, local, regional and international agencies, research institutions and private-sector companies for outstanding success in implementing development oriented strategies that leverage the power of AI and ICTs.

Creating the AI Repository was one of the action items of last year’s AI for Good Global Summit.

We are looking forward to your submissions.

If you have any questions, please send an email to: ai@itu.int

“Your project won’t be visible immediately as we have to vet the submissions to weed out spam-type material and projects that are not in line with our goals,” says Werner. That said, there are already 29 projects in the repository. As you might expect, the UK, China, and US are in the repository but also represented are Egypt, Uganda, Belarus, Serbia, Peru, Italy, and other countries not commonly cited when discussing AI research.

Werner also pointed out in response to my surprise over the ITU’s role with regard to this AI initiative that the ITU is the only UN agency which has 192* member states (countries), 150 universities, and over 700 industry members as well as other member entities, which gives them tremendous breadth of reach. As well, the organization, founded originally in 1865 as the International Telegraph Convention, has extensive experience with global standardization in the information technology and telecommunications industries. (See more in their Wikipedia entry.)

Finally

There is a bit more about the summit on the ITU’s AI for Good Global Summit 2018 webpage,

The 2nd edition of the AI for Good Global Summit will be organized by ITU in Geneva on 15-17 May 2018, in partnership with XPRIZE Foundation, the global leader in incentivized prize competitions, the Association for Computing Machinery (ACM) and sister United Nations agencies including UNESCO, UNICEF, UNCTAD, UNIDO, Global Pulse, UNICRI, UNODA, UNIDIR, UNODC, WFP, IFAD, UNAIDS, WIPO, ILO, UNITAR, UNOPS, OHCHR, UN UniversityWHO, UNEP, ICAO, UNDP, The World Bank, UN DESA, CTBTOUNISDRUNOG, UNOOSAUNFPAUNECE, UNDPA, and UNHCR.

The AI for Good series is the leading United Nations platform for dialogue on AI. The action​​-oriented 2018 summit will identify practical applications of AI and supporting strategies to improve the quality and sustainability of life on our planet. The summit will continue to formulate strategies to ensure trusted, safe and inclusive development of AI technologies and equitable access to their benefits.

While the 2017 summit sparked the first ever inclusive global dialogue on beneficial AI, the action-oriented 2018 summit will focus on impactful AI solutions able to yield long-term benefits and help achieve the Sustainable Development Goals. ‘Breakthrough teams’ will demonstrate the potential of AI to map poverty and aid with natural disasters using satellite imagery, how AI could assist the delivery of citizen-centric services in smart cities, and new opportunities for AI to help achieve Universal Health Coverage, and finally to help achieve transparency and explainability in AI algorithms.

Teams will propose impactful AI strategies able to be enacted in the near term, guided by an expert audience of mentors representing government, industry, academia and civil society. Strategies will be evaluated by the mentors according to their feasibility and scalability, potential to address truly global challenges, degree of supporting advocacy, and applicability to market failures beyond the scope of government and industry. The exercise will connect AI innovators with public and private-sector decision-makers, building collaboration to take promising strategies forward.

“As the UN specialized agency for information and communication technologies, ITU is well placed to guide AI innovation towards the achievement of the UN Sustainable Development ​Goals. We are providing a neutral close quotation markplatform for international dialogue aimed at ​building a ​common understanding of the capabilities of emerging AI technologies.​​” Houlin Zhao, Secretary General ​of ITU​

Should you be close to Geneva, it seems that registration is still open. Just go to the ITU’s AI for Good Global Summit 2018 webpage, scroll the page down to ‘Documentation’ and you will find a link to the invitation and a link to online registration. Participation is free but I expect that you are responsible for your travel and accommodation costs.

For anyone unable to attend in person, the summit will be livestreamed (webcast in real time) and you can watch the sessions by following the link below,

https://www.itu.int/en/ITU-T/AI/2018/Pages/webcast.aspx

For those of us on the West Coast of Canada and other parts distant to Geneva, you will want to take the nine hour difference between Geneva (Switzerland) and here into account when viewing the proceedings. If you can’t manage the time difference, the sessions are being recorded and will be posted at a later date.

*’132 member states’ corrected to ‘192 member states’ on May 11, 2018 at 1500 hours PDT.

*Redundant ‘and’ removed on July 19, 2018.

Burning coal produces harmful titanium dioxide nanoparticles

It turns out that Canada has the fifth largest reserve of coal in the world, according to the Coal in Canada Wikipedia entry (Note: Links have been removed),

Coal reserves in Canada rank fifth largest in the world (following the former Soviet Union, the United States, the People’s Republic of China and Australia) at approximately 10 billion tons, 10% of the world total.[1] This represents more energy than all of the oil and gas in the country combined. The coal industry generates CDN$5 billion annually.[2] Most of Canada’s coal mining occurs in the West of the country.[3] British Columbia operates 10 coal mines, Alberta 9, Saskatchewan 3 and New Brunswick one. Nova Scotia operates several small-scale mines, Westray having closed following the 1992 disaster there.[4]

So, this news from Virginia holds more than the usual interest for me (I’m in British Columbia). From an Aug. 8, 2017 Virginia Tech news release (also on EurekAlert),

Environmental scientists led by the Virginia Tech College of Science have discovered that the burning of coal produces incredibly small particles of a highly unusual form of titanium oxide.

When inhaled, these nanoparticles can enter the lungs and potentially the bloodstream.

The particulates — known as titanium suboxide nanoparticles — are unintentionally produced as coal is burned, creating these tiniest of particles, as small as 100 millionths of a meter [emphasis mine], said the Virginia Tech-led team. When the particles are introduced into the air — unless captured by high-tech particle traps — they can float away from power plant stacks and travel on air currents locally, regionally, and even globally.

As an example of this, these nanoparticles were found on city streets, sidewalks, and in standing water in Shanghai, China.

The findings are published in the latest issue of Nature Communications under team leader Michael F. Hochella Jr., University Distinguished Professor of Geosciences with the College of Science, and Yi Yang, a professor at East China Normal University in Shanghai. Other study participants include Duke University, the University of Kentucky, and Laurentian University in Canada.

“The problem with these nanoparticles is that there is no easy or practical way to prevent their formation during coal burning,” Hochella said, adding that in nations with strong environmental regulations, such as the United States, most of the nanoparticles would be caught by particle traps. Not so in Africa [a continent not a nation], China, or India, where regulations are lax or nonexistent, with coal ash and smoke entering the open air.

“Due to advanced technology used at U.S.-based coal burning power plants, mandated by the Clean Air Act and the Environmental Protection Agency, most of these nanoparticles and other tiny particles are removed before the final emission of the plant’s exhaust gases,” Hochella said. “But in countries where the particles from the coal burning are not nearly so efficiently removed, or removed at all, these titanium suboxide nanoparticles and many other particle types are emitted into the atmosphere, in part resulting in hazy skies that plague many countries, especially in China and India.”

Hochella and his team found these previously unknown nanoparticles not only in coal ash from around the world and in the gaseous waste emissions of coal plants, but on city streets, in soils and storm water ponds, and at wastewater treatment plants.

“I could not believe what I have found at the beginning, because they had been reported so extremely rarely in the natural environment,” said Yang, who once worked as a visiting professor in Virginia Tech’s Department of Geosciences with Hochella. “It took me several months to confirm their occurrence in coal ash samples.”

The newly found titanium suboxide — called Magnéli phases — was once thought rare, found only sparingly on Earth in some meteorites, from a small area of rock formations in western Greenland, and occasionally in moon rocks. The findings by Hochella and his team indicate that these nanoparticles are in fact widespread globally. They are only now being studied for the first time in natural environments using powerful electron microscopes.

Why did the discovery occur now? According to the report, nearly all coal contains traces of the minerals rutile and/or anatase, both “normal,” naturally occurring, and relatively inert titanium oxides, especially in the absence of light. When those minerals are burned in the presence of coal, research found they easily and quickly converted to these unusual titanium suboxide nanoparticles. The nanoparticles then become entrained in the gases that leave the power plant.

When inhaled, the nanoparticles enter deep into the lungs, potentially all the way into the air sacs that move oxygen into our bloodstream during the normal breathing process. While human lung toxicity of these particles is not yet known, a preliminary biotoxicity test by Hochella and Richard Di Giulio, professor of environmental toxicology, and Jessica Brandt, a doctoral candidate, both at Duke University, indicates that the particles do indeed have toxicity potential.

According to the team, further study is clearly needed, especially biotoxicity testing directly relevant to the human lung. Partnering with coal-power plants either in the United States or China would be ideal, said Yang.

More troubling, the study shows that titanium suboxide nanoparticles are biologically active in the dark, making the particles highly suspect. Exact human health effects are yet unknown.

“Future studies will need to very carefully investigate and access the toxicity of titanium suboxide nanoparticles in the human lung, and this could take years, a sobering thought considering its potential danger,” Hochella said.

As the titanium suboxide nanoparticle itself is produced incidentally, Hochella and his team came across the nanoparticle by accident while studying a 2014 coal ash spill in the Dan River, North Carolina. During the study of the downstream movement of toxic metals in the ash in the Dan River, the team discovered and recognized the presence of small amounts of the highly unusual titanium suboxide.

The group later produced the titanium suboxide nanoparticles when burning coal in a lab simulation.

This new potential air pollution health hazard builds on already established findings from the World Health Organization. It estimates that 3.3 million premature deaths occur worldwide per year due to polluted air, Hochella said. In China, 1.6 million premature deaths are estimated annually due to cardiovascular and respiratory injury from air pollution. Most Chinese megacities top 100 severely hazy days each year with particle concentrations two to four times higher than WHO guidelines, Yang said.

Direct health effects on humans is only one factor. Findings of thousands of scientists have determined that the biggest driver of warming of the planet and the resulting climate change is industrial-scale coal burning. The impact of titanium suboxide nanoparticles found in the atmosphere, in addition to greenhouse gases, on animals, water, and plants is not yet known.

They’ve used an unusual unit of measurement, “100 millionths of a meter,” nanoparticles are usually described in nanometers.

Here’s a link to and a citation for the paper,

Discovery and ramifications of incidental Magnéli phase generation and release from industrial coal-burning by Yi Yang, Bo Chen, James Hower, Michael Schindler, Christopher Winkler, Jessica Brandt, Richard Di Giulio, Jianping Ge, Min Liu, Yuhao Fu, Lijun Zhang, Yuru Chen, Shashank Priya, & Michael F. Hochella Jr. Nature Communications 8, Article number: 194 (2017) doi:10.1038/s41467-017-00276-2 Published online: 08 August 2017

This paper is behind a paywall.

This put me in mind of the famous London smog, which one doesn’t hear about much anymore. For anyone not familiar with that phenomenon, here’s more from the Great Smog of London Wikipedia entry (Note: Links have been removed),

The Great Smog of London, or Great Smog of 1952 sometimes called the Big Smoke,[1] was a severe air-pollution event [emphasis mine] that affected the British capital of London in December 1952. A period of cold weather, combined with an anticyclone and windless conditions, collected airborne pollutants – mostly arising from the use of coal [emphasis mine]– to form a thick layer of smog over the city. It lasted from Friday, 5 December to Tuesday, 9 December 1952 and then dispersed quickly when the weather changed.

It caused major disruption by reducing visibility and even penetrating indoor areas, far more severe than previous smog events experienced in the past, called “pea-soupers”. Government medical reports in the following weeks, however, estimated that up until 8 December, 4,000 people had died as a direct result of the smog and 100,000 more were made ill by the smog’s effects on the human respiratory tract. More recent research suggests that the total number of fatalities was considerably greater, about 12,000.[2]

London had suffered since the 1200s from poor air quality,[3] which worsened in the 1600s,[4][5] but the Great Smog is known to be the worst air-pollution event in the history of the United Kingdom,[6] and the most significant in terms of its effect on environmental research, government regulation, and public awareness of the relationship between air quality and health.[2][4] It led to several changes in practices and regulations, including the Clean Air Act 1956. …

Australia’s nanopatch: a way to eliminate needle vaccinations

Tristan Clemons has written a Nov. 9, 2016 essay for The Conversation on one of my favourite stories, the nanopatch,

Who likes getting a needle? I know I definitely don’t.

Someone else who doesn’t is Mark Kendall from the University of Queensland, winner of the Young Florey Medal 2016.

Mark’s work in developing the nanopatch has provided a clear pathway for vaccine delivery science to move beyond 160 year-old needle and syringe technology.

… There are approximately 20,000 projections per square centimeter on each patch, each around 60 to 100 micrometres in length. One micrometre is one million times smaller than a metre, so the height of these tiny spikes is approximately the width of a human hair.

The nanopatch is produced using a technique known as “deep reactive ion etching”, which essentially makes use of ions (charged atoms) in an electric field to selectively etch the surface of a material away. Controlling the electric field and the ions allows a high degree of control, so the microprojections are regularly spaced and of similar dimensions.

An added advantage of this approach is it has been used in the electronic circuit and solar energy industries for many years, and has the potential for increasing the scale of production.

The tiny projections on each nanopatch are invisible to the naked eye, but are long enough to breach the outermost skin layer, the stratum corneum. The stratum corneum is a layer of dead skin cells which acts as the first barrier in protecting us from infection and skin water loss.

The nanopatch projections penetrate through the stratum corneum to reach the living skin layers directly below, the epidermis and the dermis. In the epidermis are several types of immune cells that are vital for the vaccine to work.

Hence the nanopatch is well suited to the delivery of vaccines where targeting immune cells is vital for vaccination success. Examples include influenza, polio and cholera.

Mark Kendall and his colleagues have shown they are able to coat nanopatch microprojections with a vaccine, apply the nanopatch to the skin and achieve vaccination with one tenth to one thirtieth of the dose required using traditional needle and syringe approaches.

… it’s more than just a good idea. Mark Kendall and his colleagues are now running human clinical trials of nanopatches in Brisbane, and the WHO is planning a polio vaccine trial in Cuba in 2017.

The latest information I have about this research is from a Feb. 26, 2016 University of Queensland press release,

Needle-free Nanopatch technology developed at The University of Queensland has been used to successfully deliver an inactivated poliovirus vaccine.

Delivery of a polio vaccine with the Nanopatch was demonstrated by UQ’s Professor Mark Kendall and his research team at UQ’s Australian Institute for Bioengineering and Nanotechnology, in collaboration with the World Health Organisation, the US Centres for Disease Control and Prevention, and vaccine technology company Vaxxas.

Professor Kendall said the Nanopatch had been used to administer an inactivated Type 2 poliovirus vaccine in a rat model.

“We compared the Nanopatch to the traditional needle and syringe, and found that there is about a 40-fold improvement in delivered dose-sparing,” Professor Kendall said.

“This means about 40 times less polio vaccine was needed in Nanopatch delivery to generate a functional immune response as the needle and syringe.

“To our knowledge, this is the highest level of dose-sparing observed for an inactivated polio vaccine in rats achieved by any type of delivery technology, so this is a key breakthrough.”

The next step will be clinical testing.

Dr David Muller, first author of the research published in Scientific Reports, said the work demonstrated a key advantage of the Nanopatch.

“The Nanopatch targets the abundant immune cell populations in the skin’s outer layers; rather than muscle, resulting in a more efficient vaccine delivery system,” he said.

Clinical success and widespread use of the Nanopatch against polio could help in the current campaign to eradicate polio. It could be produced and distributed at a cheaper cost, and its ease of use would make it suitable for house-to-house vaccination efforts in endemic areas with only minimal training required.

World Health Organisation Global Polio Eradication Initiative Director Mr Michel Zaffran said only Afghanistan and Pakistan remained polio-endemic, but all countries were at risk until the disease was eradicated everywhere.

“Needle-free microneedle patches such as the Nanopatch offer great promise for reaching more children with polio vaccine as well as other antigens such as measles vaccine, particularly in hard-to-reach areas or areas with inadequate healthcare infrastructure,” Mr Zaffran said.

Nanopatch technology is being commercialised by Vaxxas Pty Ltd, which has scaled the Nanopatch from use in small models to prototypes for human use.

Vaxxas CEO Mr David Hoey said the first human vaccination studies are scheduled for this year [2016].

“Key attributes of the Nanopatch, including its ease of use and potential to not require refrigeration, could improve the reach and efficiency of vaccination campaigns in difficult-to-reach locations, including those where polio remains endemic,” Mr Hoey said.

The work was funded by the World Health Organisation, Vaxxas, Rotary District 9630 and the Rotary Foundation.

Here’s a link to and a citation for the paper,

Inactivated poliovirus type 2 vaccine delivered to rat skin via high density microprojection array elicits potent neutralising antibody responses by David A. Muller, Frances E. Pearson, Germain J.P. Fernando, Christiana Agyei-Yeboah, Nick S. Owens, Simon R. Corrie, Michael L. Crichton, Jonathan C.J. Wei, William C. Weldon, M. Steven Oberste, Paul R. Young, & Mark A. F. Kendall. Scientific Reports 6, Article number: 22094 (2016) doi:10.1038/srep22094 Published online: 25 February 2016

This paper is open access.

As befitting a ‘favourite story’, I’ve been following it for a number of years starting with this April 23, 2009 posting (scroll down about 25% of the way) although you might prefer to read this more substantive July 26, 2010 posting. The last time (Aug. 3, 2011 posting) I featured the story, it was to announce an investment of AUD $15M in Vaxxas (Kendall is not listed as member of the company) in order to bring the nanopatch to market.

A couple of lawyers talk wrote about managing nanotechnology risks

Because they are lawyers, I was intrigued by a Nov. 4, 2015 article on managing nanotechnology risks by Michael Lisak and James Mizgala of Sidley Austin LLP for Industry Week. I was also intrigued by the language (Note: A link has been removed),

The inclusion of nanotechnologies within manufacturing processes and products has increased exponentially over the past decade. Fortune recently noted that nanotechnology touches almost all Fortune 500 companies and that the industry’s $20 billion worldwide size is expected to double over the next decade. [emphasis mine]

Yet, potential safety issues have been raised and regulatory uncertainties persist. As such, proactive manufacturers seeking to protect their employees, consumers, the environment and their businesses – while continuing to develop, manufacture and market their products – may face difficult choices in how to best navigate this challenging and fluid landscape, while avoiding potential “nanotort,”  [emphasis mine] whistleblower, consumer fraud and regulatory enforcement lawsuits. Doing so requires forward-thinking advice based upon detailed analyses of each manufacturer’s products and conduct in the context of rapidly evolving scientific, regulatory and legal developments.

I wonder how many terms lawyers are going to coin in addition to “nanotort”?

The lawyers focus largely on two types of nanoparticles, carbon nanotubes, with a special emphasis on multi-walled carbon nantubes (MWCNT) and nano titanium dioxide,

Despite this scientific uncertainty, international organizations, such as the International Agency for Research on Cancer [a World Health Organization agency], have already concluded that nano titanium dioxide in its powder form and multi-walled carbon nanotube-7 (“MWCNT-7”) [emphasis mine] are “possibly carcinogenic to humans.” As such, California’s Department of Public Health lists titanium dioxide and MWCNT-7 as “ingredients known or suspected to cause cancer, birth defects, or other reproductive toxicity as determined by the authoritative scientific bodies.”  Considering that processed (i.e., non-powdered) titanium dioxide is found in products like toothpaste, shampoo, chewing gum and candies, it is not surprising that some have focused upon such statements.

There’s a lot of poison in the world, for example, apples contain seeds which have arsenic in them and, for another, peanuts can be carcinogenic and they can also kill you, as they are poison to people who are allergic to them.

On the occasion of Dunkin’ Donuts removing nano titanium dioxide as an ingredient in the powdered sugar used to coat donuts, I wrote a March 13, 2015 posting, where I quote extensively from Dr. Andrew Maynard’s (then director of the University of Michigan Risk Science Center now director of the Risk Innovation Lab at Arizona State University) 2020 science blog posting about nano titanium dioxide and Dunkin’ Donuts,

He describes some of the research on nano titanium dioxide (Note: Links have been removed),

… In 2004 the European Food Safety Agency carried out a comprehensive safety review of the material. After considering the available evidence on the same materials that are currently being used in products like Dunkin’ Donuts, the review panel concluded that there no evidence for safety concerns.

Most research on titanium dioxide nanoparticles has been carried out on ones that are inhaled, not ones we eat. Yet nanoparticles in the gut are a very different proposition to those that are breathed in.

Studies into the impacts of ingested nanoparticles are still in their infancy, and more research is definitely needed. Early indications are that the gastrointestinal tract is pretty good at handling small quantities of these fine particles. This stands to reason given the naturally occurring nanoparticles we inadvertently eat every day, from charred foods and soil residue on veggies and salad, to more esoteric products such as clay-baked potatoes. There’s even evidence that nanoparticles occur naturally inside the gastrointestinal tract.

You can find Andrew’s entire discussion in his March 12, 2015 post on the 2020 Science blog. Andrew had written earlier in a July 12, 2014 posting about something he terms ‘nano donut math’ as reported by As You Sow, the activist group that made a Dunkin’ Donuts shareholder proposal which resulted in the company’s decision to stop using nano titanium dioxide in the powdered sugar found on their donuts. In any event, Andrew made this point,

In other words, if a Dunkin’ Donut Powdered Cake Donut contained 8.9 mg of TiO2 particles smaller than 10 nm, it would have to have been doused with over 1 million tons of sugar coating! (Note update at the end of this piece)

Clearly something’s wrong here – either Dunkin’ Donuts are not using food grade TiO2 but a nanopowder with particle so small they would be no use whatsoever in the sugar coating (as well as being incredibly expensive, and not FDA approved).  Or there’s something rather wrong with the analysis!

If it’s the latter – and it’s hard to imagine any other plausible reason for the data – it looks like As You Sow ended up using rather dubious figures to back up their stakeholder resolution.  I’d certainly be interested in more information on the procedures Analytical Sciences used and the checks and balances they had in place, especially as there are a number of things that can mess up a particle analysis like this.

Update July 14: My bad, I made a slight error in the size distribution calculation first time round.  This has been corrected in the article above.  Originally, I cited the estimated Mass Median Diameter (MMD) of the TiO2 particles as 167 nm, and the Geometric Standard Deviation (GSD) as 1.6.  Correcting an error in the Excel spreadsheet used to calculate the distribution (these things happen!) led to a revised estimate of MMD = 168 nm and a GSD of 1.44.  These may look like subtle differences, but when calculating the estimated particle mass below 10 nm, they make a massive difference.  With the revised figures, you’d expect less than one trillionth of  a percent of the mass of the TiO2 powder to be below 10 nm!! (the original estimate was a tenth of a millionth of a percent).  In other words – pretty much nothing!  The full analysis can be found here.

Update November 16 2014.  Based on this post, As You Sow checked the data from Analytical Sciences LLC and revised the report accordingly.  This is noted above.

It would seem that if there are concerns over nano titanium dioxide in food, the biggest would not be the amounts ingested by consumers but inhalation by workers should they breathe in large quantities when they are handling the material.

As for the MWCNTs, they have long raised alarms but most especially the long MWCNTs and for people handling them during the course of their work day. Any MWCNTs found in sports equipment and other consumer products are bound in the material and don’t pose any danger of being inhaled into the lungs, unless they should be released from their bound state (e.g. fire might release them).

After some searching for MWCNT-7, I found something which seems also to be known as Mitsui MWCNT-7 or Mitsui 7-MWCNT (here’s one of my sources). As best I understand it, Mitsui is a company that produces an MWCNT which they have coined an MWCNT-7 and which has been used in nanotoxicity testing. As best I can tell, MWCNT is MWCNT-7.

The lawyers (Lisak and Mizgala) note things have changed for manufacturers since the early days and they make some suggestions,

One thing is certain – gone are the days when “sophisticated” manufacturers incorporating nanotechnologies within their products can reasonably expect to shield themselves by pointing to scientific and regulatory uncertainties, especially given the amount of money they are spending on research and development, as well as sales and marketing efforts.

Accordingly, manufacturers should consider undertaking meaningful risk management analyses specific to their applicable products. …

First, manufacturers should fully understand the life-cycle of nanomaterials within their organization. For some, nanomaterials may be an explicit focus of innovation and production, making it easier to pinpoint where nanotechnology fits into their processes and products. For others, nanomaterials may exist either higher-up or in the back-end of their products’ supply chain. …

Second, manufacturers should understand and stay current with the scientific state-of-the-art as well as regulatory requirements and developments potentially applicable to their employees, consumers and the environment. An important consideration related to efforts to understand the state-of-the-art is whether or not manufacturers should themselves expend resources to advance “the science” in seeking to help find answers to some of the aforementioned uncertainties. …

The lawyers go on to suggest that manufacturers should consider proactively researching nanotoxicity so as to better defend themselves against any future legal suits.

Encouraging companies to proactive with toxicity issues is in line with what seems to be an international (Europe & US) regulatory movement putting more onus on producers and manufacturers to take responsibility for safety testing. (This was communicated to me in a conversation I had with an official at the European Union Joint Research Centre where he mentioned REACH regulations and the new emphasis in response to my mention of similar FDA (US Food and Drug Administration) regulations. (We were at the 2014 9th World Congress on Alternatives to Animal Testing in Prague, Czech republic.)

For anyone interested in the International Agency for Research on Cancer you can find it here.

Hong Kong, MosquitNo, and Dengue fever

The most substantive piece I’ve written on dengue fever and a nanotechnology-enabled approach to the problem was a 2013 post explaining why the fever is of such concern, which also included information about a proposed therapeutic intervention by Nanoviricides. From the July 2, 2013 posting, here’s more about the magnitude of the problem,

… the WHO (World Health Organization) fact sheet no. 117,

The incidence of dengue has grown dramatically around the world in recent decades. Over 2.5 billion people – over 40% of the world’s population – are now at risk from dengue. WHO currently estimates there may be 50–100 million dengue infections worldwide every year.

Before 1970, only nine countries had experienced severe dengue epidemics. The disease is now endemic in more than 100 countries in Africa, the Americas, the Eastern Mediterranean, South-east Asia and the Western Pacific. The American, South-east Asia and the Western Pacific regions are the most seriously affected.

Cases across the Americas, South-east Asia and Western Pacific have exceeded 1.2 million cases in 2008 and over 2.3 million in 2010 (based on official data submitted by Member States). Recently the number of reported cases has continued to increase. In 2010, 1.6 million cases of dengue were reported in the Americas alone, of which 49 000 cases were severe dengue.

Not only is the number of cases increasing as the disease spreads to new areas, but explosive outbreaks are occurring. The threat of a possible outbreak of dengue fever now exists in Europe and local transmission of dengue was reported for the first time in France and Croatia in 2010 and imported cases were detected in three other European countries. A recent (2012) outbreak of dengue on Madeira islands of Portugal has resulted in over 1800 cases and imported cases were detected in five other countries in Europe apart from mainland Portugal.

An estimated 500 000 people with severe dengue require hospitalization each year, a large proportion of whom are children. About 2.5% of those affected die.

Fast forwarding to 2015, this latest information about dengue fever features a preventative approach being taken in Hong Kong according to a July 5, 2015 article by Timmy Sung  for the South China Morning Post,

Dutch insect repellent innovator Mosquitno targets Hong Kong as dengue fever cases rise

A Dutch company says it has invented an insect repellent using nanotechnology which can keep clothes and homes mosquito-free for up to three months.

Mosquitno has been invited by a government body to begin trading in Hong Kong as the number of cases reported in the city of the deadly mosquito-borne dengue fever rises.

The new repellent does not include the active ingredient used in many insect repellents, DEET, which has question marks surrounding its safety.

Figures from the Department of Health show the number of dengue fever cases reported rose 8 per cent last year, to 112. There were 34 cases in the first five months of this year, 36 per cent more than in the same period last year. Mosquitoes are most active in the summer months.

MosquitNo does use an ingredient, IR3535, which has caused concern (from Sung’s article),

The Consumer Council has previously warned that IR3535-based mosquito repellents can break down plastic materials and certain synthetic fibres, but Wijnen [Erwin Wijnen, director of the {Mosqutino’s} brand development and global travel retailing] said the ingredient combined with nanotechnology is safe and there was no possibility it would damage clothes.

I was not able to find out more about the company’s nanotechnology solution as applied to MosquitNo,

The NANO Series is a revolutionary, innovative technology designed by scientists especially for MosquitNo. This line utilizes this-breaking insect repellent technology in various products including wipes, textile spray, fabric softener and bracelets. This technology and our trendy applications are truly industry-changing and MosquitNo is at the leading edge!

The active component in all our awesome products within this range is IR3535.

That’s it for technical detail. At least, for now.

2014 Maddox Prize winners and more ( a letter writing compaign)* from Sense about Science*

The UK’s ‘Sense about Science’ organization announced the two winners of its 2014 John Maddox (aka, the ‘standing up for science’) Prize in late October 2014 (from the Oct. 28, 2014 announcement),

I am delighted to share that last night [Oct. 27, 2014] Dr Emily Willingham and Dr David Robert Grimes were announced as the winners of the 2014 John Maddox Prize, at our annual reception held with the Royal Pharmaceutical Society.

After lengthy deliberation, this year’s judges (Tracey Brown, Philip Campbell, Colin Blakemore and Martin Rees) awarded the prize to these two people who embody the spirit of the prize, showing courage in promoting science and evidence on a matter of public interest, despite facing difficulty and hostility in doing so.

The call for 2014 nominations was mentioned in an Aug. 18, 2014 post. Here’s more about each of the winners (from the 2014 John Maddox Prize webpage on the Sense about Science website),

The judges awarded the prize to freelance journalist Dr Emily Willingham and early career scientist Dr David Robert Grimes for courage in promoting science and evidence on a matter of public interest, despite facing difficulty and hostility in doing so. …

David Grimes writes bravely on challenging and controversial issues, including nuclear power and climate change. He has persevered despite hostility and threats, such as on his writing about the evidence in the debate on abortion in Ireland. He does so while sustaining his career as a scientist at the University of Oxford.

Emily Willingham, a US writer, has brought discussion about evidence, from school shootings to home birth, to large audiences through her writing. She has continued to reach across conflict and disputes about evidence to the people trying to make sense of them. She is facing a lawsuit for an article about the purported link between vaccines and autism.

A Nov. 1, 2014 post by Nick Cohen for the Guardian newspaper discusses one of the 2014 winners in the context of a post about standing up to science ignorance and Ebola in the US, scroll down abut 15% of the way),

The joint winners confronted beliefs that are as prevalent in Britain as America: that vaccination causes autism, that homeopathic medicines work, that manmade climate change does not exist and that adding fluoride to the water supply is a threat to health. (I didn’t know it until the prize jury told me but Sinn Féin is leading a vigorous anti-fluoride campaign in Dublin – well, I suppose it’s progress for the IRA to go from blowing off peoples’ heads to merely rotting their teeth.)

David Robert Grimes, one of the winners, said that, contrary to the myth of the scientific bully, most of his colleagues wanted to keep out of public debate, presumably because they did not wish to receive the threats of violence fanatics and quacks have directed at him. If we are to improve public policy in areas as diverse as the fight against Ebola to the treatment of drug addicts, they need to be a braver, and more willing to tell the public, which so often funds their research, what they have learned.

Grimes makes a useful distinction. Most people just want more information and scientists should be prepared to make their case clearly and concisely. Then there are the rest – Ukip, the Tea Party, governors of Maine, Sinn Féin, David Cameron, climate change deniers – who will block out any evidence that contradicts their beliefs. They confirm the truth of Paul Simon’s line: “All lies and jest, still the man hears what he wants to hear and disregards the rest.”

Lydia Lepage (a post-doctoral researcher at the University of Edinburgh and a member of the Voice of Young Science, which is run by Sense About Science) over on the Conversation writes about both winners in an Oct. 28, 2014 post (Note: Links have been removed),

Willingham is a freelance science journalist whose evidence-based article: “Blame Wakefield for missed autism-gut connection” drew intense criticism and a lawsuit from Andrew Wakefield, the discredited scientist known for his now-retracted 1998 Lancet paper on the alleged link between vaccines and autism. She criticised the “red herring and the subsequent noxious cloud that his fraud left over any research examining autism and the gut”.

Willingham’s self-declared passion is “presenting accurate, evidence-based information”. She says:

Standing up for science and public health in the face of not only unyielding but also sometimes threatening opposition can be tiring and demoralising.

Grimes is a post-doctoral researcher at the University of Oxford in the UK, working on modelling oxygen distribution in tumours. He has been awarded the Maddox Prize for reaching out to the public through his writing on a range of challenging and controversial issues, including nuclear power and climate change.

Grimes continues to present the evidence, despite receiving threats, particularly surrounding discussion on abortion in Ireland. Following his article on six myths about cancer, in which he addressed the “dubious and outlandish” information that can be found on the internet, he received physical and digital hate-mail.

Sense about Science next announced an ‘Ask for Evidence’ website, from a Nov. 2, 2014 announcement,

We are excited to announce that Ask for Evidence online is now live! And people are already using it to ask for the evidence behind claims they’ve come across. Check out www.askforevidence.org

It’s our new interactive website that makes asking for evidence and getting help understanding that evidence as easy as possible. You can use it to ask politicians, companies, NGOs and anyone else for evidence behind their claims, while you’re on the train, walking down the street or sitting in front of the TV. And if you need help understanding the evidence you’ve been sent, that’s there too. With the help of partners and friends we’ve built a help centre that has captured what we’ve learnt over the past 12 years answering thousands of requests for help in understanding evidence.

Finally,. there’s the latest announcement about an effort to influence the World Health Organization’s (WHO) new policy on reporting the results of clinical trials, from the Nov. 11, 2014 announcement,

Following our pressure, the World Health Organization is drafting a policy on reporting the results of clinical trials.

We have to grab this fantastic opportunity with both hands and make sure that the most influential health body in the world comes out with a statement that strongly supports clinical trials transparency.

But you only have until Saturday 15th November 2014 to add your voice.

The draft WHO policy does not call for the disclosure of the results of past trials, only future ones. The vast majority of medicines we use every day were approved by regulators a decade or more ago and so were tested in clinical trials over the past decades.

So email the WHO to tell them their policy should:

  1. Call for the results of all past clinical trials to be reported, as well as all future clinical trials.
  2. Require results to be reported within 12 months, rather than permitting delays of 18-30 months. The USA’s FDA Amendment Act, the newly adopted EU Clinical Trials Regulation and pharmaceutical companies including GSK and LEO Pharma all agree that 12 months is enough time to report results.
  3. Encourage researchers to put results on publicly accessible registers, in useful, standardised formats.

Email ictrpinfo@who.int today.

Be sure to include your name and contact details as the WHO will not consider anonymous comments.

You can also use the full AllTrials response to write your email if you wish.

Read the full AllTrials response.

I am encouraged to see a move towards more transparency in reporting the results of clinical trials whether or not this bid to include past clinical trials is successful, although that would certainly be excellent news.

* (a letter writing campaign) was added to the head and ‘sense about science’ was changed to ‘Sense about Science’ on Nov. 14, 2014 1015 hundred hours PDT.

Treatment for patients infected with the ebola virus (a response to crisis in West African countries)

I’ve not actively kept up with the situation in the West African countries suffering an outbreak of the ebola virus other than to note that it is ongoing. My Aug. 15, 2014 post provides a snapshot of the situation and various new treatments, including one based on tobacco, which could be helpful but appeared not to have been tested and/or deployed. There was a lot of secrecy (especially from Medicago, a Canadian company) regarding the whole matter of treatments and vaccines.

There seem to have been some new developments on the treatment side, involving yet another Canadian company, Tekmira, according to a Sept. 23, 2013 news item on Azonano,

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, today announced that the FDA [US Food and Drug Administration] has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections.

A Sept. 22, 2014 Tekmira news release, which originated the news item, expands on the topic of regulatory issues associated with bringing this treatment to the areas suffering the outbreak,

“Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients. We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients,” said Dr. Mark J. Murray Tekmira’s President and CEO.

“We have insisted on acting responsibly in the interest of patients and our stakeholders,” added Dr. Murray. “Today we are reporting that, working closely with regulators in the United States and Canada, we have established a framework for TKM-Ebola use in multiple patients. In the US, the FDA has granted expanded access use of TKM-Ebola under our Investigational New Drug application (IND) and Health Canada has established a similar framework, both of which allow the use of our investigational therapeutic in more patients.”

“We have already responded to requests for the use of our investigational agent in several patients under emergency protocols, in an effort to help these patients, a goal we share with the FDA and Health Canada. TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated. However, it must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials. These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome,” said Dr. Murray. “Our TKM-Ebola drug supplies are limited, but we will continue to help where we can, as we continue to focus on the other important objectives we have to advance therapies to meet the unmet needs of patients.”

TKM-Ebola is an investigational therapeutic, being developed under an FDA approved IND, which is currently the subject of a partial clinical hold under which the FDA has allowed the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection.

About FDA Expanded Access Program

Expanded access is the use of an investigational drug outside of a clinical trial to treat a patient, with a serious or immediately life-threatening disease or condition, who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. (Source: www.fda.com)

About TKM-Ebola, an Anti-Ebola Virus RNAi Therapeutic

TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP [Lipid Nanoparticle] technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol. 375, May 29, 2010). In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.

About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)

This work is being conducted under contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefense response capability. For more information, visit www.jpeocbd.osd.mil.

About Tekmira

Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, B.C. Canada.

Forward-Looking Statements and Information

This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements in this news release include statements about Tekmira’s strategy, future operations, clinical trials, prospects and the plans of management; an appropriate regulatory and clinical  framework for emergency use of TKM-Ebola in subjects with confirmed or suspected Ebola infections; FDA grant of expanded access use of TKM-Ebola under Tekmira’s IND; Health Canada’s establishment of a similar framework for TKM-Ebola; Tekmira’s response to requests for the use of TKM-Ebola in several patients under emergency protocols and the results thereon; the current supply of TKM-Ebola drug; the partial clinical hold on the TKM-Ebola IND by the FDA (enabling the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection); the quantum value of the contract with the JPM-MCS; and Fast Track designation from the FDA for the development of TKM-Ebola.

With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things, the clinical framework for emergency use of TKM-Ebola. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: TKM-Ebola may not prove to be effective in the treatment of Ebola infection under the emergency use framework, or at all; any uses of TKM-Ebola under emergency INDs are not controlled trails, and TKM-Ebola may be used on Ebola strains that have diverged from the strain to which TKM-Ebola is directed, and physicians treating patients may use more than one therapeutic intervention in addition to TKM-Ebola; the current supply of TKM-Ebola is limited, and Tekmira may not be able to respond to future requests for help in the current Ebola outbreak; the FDA may not remove the partial clinical hold on the TKM-Ebola IND; the FDA may refuse to approve Tekmira’s products, or place restrictions on Tekmira’s ability to commercialize its products; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; and Tekmira may not receive the necessary regulatory approvals for the clinical development of Tekmira’s products.

A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s Annual Report on Form 10-K and Tekmira’s continuous disclosure filings, which are available at www.sedar.com or www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

In the midst of all those ‘cover your rear end’ statements to investors, it’s easy to miss the fact that people are actually being treated and the results are promising, if not guaranteed,

Tekmira has distributed a Sept. 23, 2014 news release touting its membership in a new consortium, which suggests that in parallel with offering treatment, human clinical trials will  also be conducted,

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today reported that it is collaborating with an international consortium to provide an RNAi based investigational therapeutic for expedited clinical studies in West Africa.

Led by Dr. Peter Horby of the Centre for Tropical Medicine and Global Health at the University of Oxford and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), the consortium includes representatives from the World Health Organization (WHO), US Centers for Disease Control, Médecins Sans Frontières – Doctors without Borders (MSF), ISARIC, and Fondation Mérieux, among others.

The Wellcome Trust has announced it has awarded £3.2 million to the consortium to fund this initiative. The award will include funds for the manufacture of investigational therapeutics as well as the establishment of an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa. RNAi has been prioritized as an investigational therapeutic and may be selected for clinical trials at these centers.

The objective of the clinical trials is to assess the efficacy and safety of promising therapeutics and vaccines, reliably and safely, in patients with EVD by adopting strict protocols that comply with international standards.  It is hoped this initiative will permit the adoption of safe and effective interventions rapidly.

The genetic sequence of the Ebola virus variant responsible for the ongoing outbreak in West Africa is now available. Under this program, Tekmira will produce an RNAi based product specifically targeting the viral variant responsible for this outbreak.  The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.

“We commend the Wellcome Trust for their leadership in providing the necessary funds to launch and expedite this ground breaking initiative. We are gratified that RNAi has been prioritized as a potential investigational therapeutic to assist in the ongoing public health and humanitarian crisis in Africa,” said Dr. Murray, Tekmira’s President and CEO.

“We are an active collaborator in this consortium and through our ongoing dialogue with the WHO, NGOs and governments in various countries; we have been discussing the creation of appropriate clinical and regulatory frameworks for the potential use of investigational therapeutics in Africa. This initiative goes a long way towards achieving this aim.  Many complex decisions remain to fully implement this unique clinical trial platform.  At this time, there can be no assurances that our product will be selected by the consortium for clinical trials in Africa,” said Dr. Murray.

About Wellcome Trust

The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending over £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. For more information, visit www.wellcome.ac.uk

I’m glad they’re being careful while giving people treatment, i. e., trying to do something rather than waiting to conduct human clinical trials as has sometimes been the case in the past. This business of running the trials almost parallel to offering treatment suggests an agility not often associated with the international health care community.

ETA Sept. 23 2014 1200 hours PDT: For more information about the status of the Ebola outbreak read Tara Smith’s Sept. 22, 2014 article Slate titled, Here’s Where We Stand With Ebola; Even experienced international disaster responders are shocked at how bad it’s gotten (Note: Links have been removed).

Now, terms like “exponential spread” are being thrown around as the epidemic continues to expand more and more rapidly. Just last week, an increase of 700 new cases was reported, and the case count is now doubling in size approximately every three weeks.

A Doctors Without Borders worker in Monrovia, Liberia, named Jackson Naimah describes the situation in his home country, noting that patients are literally dying at the front door of his treatment center because it lacks patient beds and assistance; the sufferers are left to die a “horrible, undignified death” and potentially infect others as they do so: …

… Health care workers who are treating the sick are dying because they also lack basic protective equipment, or because they have been so overwhelmed by taking care of the ill and dying that they begin to make potentially fatal errors. They have gone on strike in Liberia because they are not being adequately protected or even paid for their risky service.

Fear and misinformation are as deadly as the virus itself. Eight Ebola workers were recently murdered in Guinea, in the area where the virus first came to the world’s attention in March. Liberia’s largest newspaper featured a story describing Ebola as a man-made virus being purposely unleashed upon Africans by Western pharmaceutical companies. Reports abound of doctors and other workers being chased away, sometimes violently, by fearful families. …

It’s not a pleasant read but, I think, a necessary one. For anyone who may think the panic and fear are unique to this situation, I once worked with a nurse who described being lifted by her neck after someone came through the door of a clinic demanding a vaccine and had been refused. He was in such a panic and so fearful he wasn’t going to take a ‘no’. The incident took place in Vancouver (Canada) in a ‘nice’ part of town.

ETA Sept. 24, 2014: Kelly Grant has written a Sept. 22, 2014 article for the Globe and Mail which provides more information about Tekmira, some of which contradicts the details I have here about TKM-Ebola and clinical trials in Africa although the key points remain the same. She also provides more information about the ZMapp therapy (mentioned in my Aug. 15, 2014 post) noting yet a third Canadian connection.* Canada’s National Microbiology Laboratory was somehow involved in developing ZMApp, unfortunately, Grant does not or is not able to provide more details about that involvement.

ETA Oct. 16, 2014: David Bruggeman recommends a digital journalism site Ebola Deeply for some in depth reporting in his Oct. 16, 2014 posting.

* This sentence “She also provides more information about the ZMapp therapy mentioned in my Aug. 15, 2014 post mentioning yet a third Canadian connection.” was altered for grammatical purposes on Dec. 4, 2014.

Bone implants and restorative dentistry at the University of Malaya

The research into biomedical implants at the University of Malaya is part of an international effort and is in response to a demographic reality, hugely increased populations of the aged. From a Sept. 18, 2014 news item on ScienceDaily,

A major success in developing new biomedical implants with the ability to accelerate bone healing has been reported by a group of scientists from the Department of Restorative Dentistry, University of Malaya. This stems from a project partly funded by HIR [High Impact Research] and also involves Mr. Alireza Yaghoubi, HIR Young Scientist.

According to WHO (World Health Organization), between 2000 and 2050, the world’s population over 60 years is expected to increase from 605 million to more than 2 billion. This trend is particularly more prominent in Asia and Europe where in some countries by 2050, the majority of people will be older than 50. That is why in recent years, regenerative medicine has been among the most active and well-funded research areas in many developing nations.

As part of this global effort to realize better treatments for age-related conditions, a group of scientists from the department of restorative dentistry, University of Malaya and four other universities in the US have recently reported a major success in developing new biomedical implants with the ability to accelerate bone healing.

Two studies were published according to the Sept.15, 2014 University of Malaya news release, which originated the news item,

The two studies funded by the National Science Fund (NSF) in the US and the High Impact Research (HIR) program in Malaysia tackled the issue of bone-implant integration from different angles. In the first study appearing on the front cover of the July issue of Applied Surface Science, researchers demonstrated a mechanically superior bioactive coating based on magnesium silicates rather than the commercially available calcium phosphate which develops microcracks during preparation and delaminates under pressure. The new material owing to its lower thermal mismatch with titanium can prolong the durability of load-bearing orthopedic implants and reduce chances of post-surgery complications.

The other study published in the American Chemical Society’s Applied Materials & Interfaces reported a method for fabricating titanium implants with special surface topographies which double the chance of cell viability in early stages. The new technique is also much simpler as compared to the existing ones and therefore enables the preparation of personalized implants at the fraction of time and cost while offering a higher mechanical reliability.

Alireza Yaghoubi, the corresponding author of both studies believes that we are moving toward a future of personalized products. “It is very much like your taste in music and TV shows. People are different and the new trend in biotechnology is to make personalized medicine that matches the patient’s needs” Yaghoubi said. He continued “With regard to implants, we have the problem of variations in bone density in patients with osteoporosis and in some cases, even healthy individuals. Finding ways to integrate the implants with bone tissues can be challenging. There are also problems with the long-term performance of implants, such as release of debris from bioactive films which can potentially lead to osteolysis and chronic inflammation”.

The new technique employed by the scientists to create titanium implants with desirable surface properties uses microwave heating to create a porosity gradient on top of a dense core. The principles are very similar to a kitchen microwave and how it can make cooking easier, however apparently the fast heating capability is not only useful in cooking but it has numerous industrial applications. Prof. Bhaduri, the Director of Multi-functional materials laboratory at University of Toledo says that they have been using microwave for years to simplify fabrication of complex metallic components. “We needed a way to streamline the process and microwave sintering was a natural fit. With our new method, making the implant from titanium powder in custom sizes and with specific surface topographies is achieved through one easy step.” Bhaduri elaborated.

Researchers are hoping to carry out the clinical trial for this new generation of implants in order to make them available to the market soon. Dr. Kutty, one of the lead authors suggests that there is still room for improvement. Kutty concluded that “Roughened surfaces and bioceramics have desirable effects on osseointegration, but we are not stopping there. We are now developing new ways to use peptides for enhancing the performance of implants even further.”

This image provides an illustration of the proposed new material for implants,

The artwork appeared on the front cover of Applied Surface Science summarizes the benefits of a new bioceramic coating versus the commercially available Calcium Phosphate which develops microcracks during processing and may later cause osteolysis in load-bearing orthopedic implants. Courtesy: University of Malaya

The artwork appeared on the front cover of Applied Surface Science summarizes the benefits of a new bioceramic coating versus the commercially available Calcium Phosphate which develops microcracks during processing and may later cause osteolysis in load-bearing orthopedic implants. Courtesy: University of Malaya

Here are links to and citations for the papers,

Electrophoretic deposition of magnesium silicates on titanium implants: Ion migration and silicide interfaces by M. Afshar-Mohajer, A. Yaghoubi, S. Ramesh, A.R. Bushroa, K.M.C. Chin, C.C. Tin, and W.S. Chiu.  Applied Surface Science (2014) , Volume 307, 15 July 2014, Pages 1–6, DOI: 10.1016/j.apsusc.2014.04.033

Microwave-assisted Fabrication of Titanium Implants with Controlled Surface Topography for Rapid Bone Healing by Muralithran G. Kutty, Alok De, Sarit B. Bhaduri, and Alireza Yaghoubi. ACS Appl. Mater. Interfaces, 2014, 6 (16), pp 13587–13593 DOI: 10.1021/am502967n Publication Date (Web): August 6, 2014

Copyright © 2014 American Chemical Society

Both of these papers are behind paywalls.

Malaria vaccine with self-assembling nanoparticles

This research was published in April 2013 so I’m not sure what has occasioned a Sept. 2014 push for publicity. Still, it’s interesting work which may lead to a more effective vaccine for malaria than some of the other solutions being tested.  From a Sept. 4, 2014 news item on Nanowerk,

A self-assembling nanoparticle designed by a University of Connecticut (UConn) professor is the key component of a potent new malaria vaccine that is showing promise in early tests.

For years, scientists trying to develop a malaria vaccine have been stymied by the malaria parasite’s ability to transform itself and “hide” in the liver and red blood cells of an infected person to avoid detection by the immune system.

But a novel protein nanoparticle developed by Peter Burkhard, a professor in the Department of Molecular & Cell Biology, in collaboration with David Lanar, an infectious disease specialist with the Walter Reed Army Institute of Research, has shown to be effective at getting the immune system to attack the most lethal species of malaria parasite, Plasmodium falciparum, after it enters the body and before it has a chance to hide and aggressively spread.

Sept. 3, 2014 University of Connecticut news release by Colin Poitras, which originated the news item, describes the particle and the research in greater detail,

The key to the vaccine’s success lies in the nanoparticle’s perfect icosahedral symmetry (think of the pattern on a soccer ball) and ability to carry on its surface up to 60 copies of the parasite’s protein. The proteins are arranged in a dense, carefully constructed cluster that the immune system perceives as a threat, prompting it to release large amounts of antibodies that can attack and kill the parasite.

In tests with mice, the vaccine was 90-100 percent effective in eradicating the Plasmodium falciparum parasite and maintaining long-term immunity over 15 months. That success rate is considerably higher than the reported success rate for RTS,S, the world’s most advanced malaria vaccine candidate currently undergoing phase 3 clinical trials, which is the last stage of testing before licensing.

“Both vaccines are similar, it’s just that the density of the RTS,S protein displays is much lower than ours,” says Burkhard. “The homogeneity of our vaccine is much higher, which produces a stronger immune system response. That is why we are confident that ours will be an improvement.

“Every single protein chain that forms our particle displays one of the pathogen’s protein molecules that are recognized by the immune system,” adds Burkhard, an expert in structural biology affiliated with UConn’s Institute of Materials Science. “With RTS,S, only about 14 percent of the vaccine’s protein is from the malaria parasite. We are able to achieve our high density because of the design of the nanoparticle, which we control.”

Here’s an image illustrating the nanoparticle,

This self-assembling protein nanoparticle relies on rigid protein structures called ‘coiled coils’ (blue and green in the image) to create a stable framework upon which scientists can attach malaria parasite antigens. Early tests show that injecting the nanoparticles into the body as a vaccine initiates a strong immune system response that destroys a malarial parasite when it enters the body and before it has time to spread. (Image courtesy of Peter Burkhard)

This self-assembling protein nanoparticle relies on rigid protein structures called ‘coiled coils’ (blue and green in the image) to create a stable framework upon which scientists can attach malaria parasite antigens. Early tests show that injecting the nanoparticles into the body as a vaccine initiates a strong immune system response that destroys a malarial parasite when it enters the body and before it has time to spread. (Image courtesy of Peter Burkhard)

The news release goes on to explain why malaria is considered a major, global health problem and how the researchers approached the problem with developing a malaria vaccine for humans,

The search for a malaria vaccine is one of the most important research projects in global public health. The disease is commonly transported through the bites of nighttime mosquitoes. Those infected suffer from severe fevers, chills, and a flu-like illness. In severe cases, malaria causes seizures, severe anemia, respiratory distress, and kidney failure. Each year, more than 200 million cases of malaria are reported worldwide. The World Health Organization estimated that 627,000 people died from malaria in 2012, many of them children living in sub-Saharan Africa.

It took the researchers more than 10 years to finalize the precise assembly of the nanoparticle as the critical carrier of the vaccine and find the right parts of the malaria protein to trigger an effective immune response. The research was further complicated by the fact that the malaria parasite that impacts mice used in lab tests is structurally different from the one infecting humans.

The scientists used a creative approach to get around the problem.

“Testing the vaccine’s efficacy was difficult because the parasite that causes malaria in humans only grows in humans,” Lanar says. “But we developed a little trick. We took a mouse malaria parasite and put in its DNA a piece of DNA from the human malaria parasite that we wanted our vaccine to attack. That allowed us to conduct inexpensive mouse studies to test the vaccine before going to expensive human trials.”

The pair’s research has been supported by a $2 million grant from the National Institutes of Health and $2 million from the U.S. Military Infectious Disease Research Program. A request for an additional $7 million in funding from the U.S. Army to conduct the next phase of vaccine development, including manufacturing and human trials, is pending.

“We are on schedule to manufacture the vaccine for human use early next year,” says Lanar. “It will take about six months to finish quality control and toxicology studies on the final product and get permission from the FDA to do human trials.”

Lanar says the team hopes to begin early testing in humans in 2016 and, if the results are promising, field trials in malaria endemic areas will follow in 2017. The required field trial testing could last five years or more before the vaccine is available for licensure and public use, Lanar says.

Martin Edlund, CEO of Malaria No More, a New York-based nonprofit focused on fighting deaths from malaria, says, “This research presents a promising new approach to developing a malaria vaccine. Innovative work such as what’s being done at the University of Connecticut puts us closer than we’ve ever been to ending one of the world’s oldest, costliest, and deadliest diseases.”

A Switzerland-based company, Alpha-O-Peptides, founded by Burkhard, holds the patent on the self-assembling nanoparticle used in the malaria vaccine. Burkhard is also exploring other potential uses for the nanoparticle, including a vaccine that will fight animal flu and one that will help people with nicotine addiction. Professor Mazhar Khan from UConn’s Department of Pathobiology is collaborating with Burkhard on the animal flu vaccine.

Here’s a link to and a citation for the paper,

Mechanisms of protective immune responses induced by the Plasmodium falciparum circumsporozoite protein-based, self-assembling protein nanoparticle vaccine by Margaret E McCoy, Hannah E Golden, Tais APF Doll, Yongkun Yang, Stephen A Kaba, Peter Burkhard, and David E Lanar. Malaria Journal 2013, 12:136 doi:10.1186/1475-2875-12-136

This is an open access article.