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FDA Stops Consumer Available Genomics Testing

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A few weeks ago, Pathway Genomics, a consumer genomics company, had planned to have its saliva kits at all US Walgreen’s drug stores. The FDA put a stop to it. Congress is now investigating the matter. What is going on here?

This segment is about the whole flap regarding consumer genomics. A few weeks ago, Pathway Genomics was going to start a United States-wide drugstore availability of their genomics kit in Walgreen’s — 7,500 drugstores around the country. In fact, it was planned in August to do the same with the CVS drugstores.

It was really interesting to watch because then the FDA sent a letter to not just Pathway, but also the other companies that do consumer genomics and genome-wide scans such as Navigenics and 23andMe, and said, “We don’t find any approval for this test.” And shortly after that, there was a Congressional investigation led by Congressman Waxman.

Why would this happen? We know that these tests, these genome-wide scans and high-throughput genotyping, are widely available through the internet and have been for more than a couple of years. Just because of the encroachment, if you will, into drugstores to have a saliva kit to be available, is this enough reason to start clamping down on these consumer genomics companies, which do very accurate high-throughput genotyping for what many would consider a reasonable price?

What appears to be the case is this kind of  Big Brother paternalistic approach that individuals don’t really have the right to have genome-wide scanning because the data are not adequate to make any medical guidance. Well, this is really kind of interesting because we know there are a lot of particularly pharmacogenomic results that actually could have a big difference, things like the response to Plavix, the inflammation that one can get after exposure to statins, even such things as just caffeine and risk of heart attack. And these were, in fact, available through Pathway Genomics for a $79 charge of all the known, established pharmacogenetic tests. Similarly, Navigenics and 23andMe are providing these.

So this is something that is really interesting — to have, essentially, regulatory governmental oversight bearing down on this group of companies. I think it is really a problem. I don’t see the difference between having these different kits available through the web as compared to having a drugstore presence.

But this is interesting and I would certainly like to get your comments. It seems to me that, in order for this whole democratization of genomics to be in the hands of consumers, this is a necessary step that is inevitable. One could argue that it is a little early, too early in the process and a lot of the data can’t really provide great individualization of risk or therapies. That may be the case, but it is a good way for consumers to learn, and certainly the prices for these types of tests have come down considerably over the years.

Soon, we will be releasing the results of our 5,000 individual cohort who had consumer genomic-wide scanning and had followup to see the impact and that will be interesting, as well.

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Scientists Recording Video of your Thoughts

November 2, 2009 Technology, privacy No Comments

video-thought-recorderScientists have discovered how to “read” minds by scanning brain activity and reproducing images of what people are seeing — or even remembering.

Researchers have been able to convert into crude video footage the brain activity stimulated by what a person is watching or recalling.

The breakthrough raises the prospect of significant benefits, such as allowing people who are unable to move or speak to communicate via visualisation of their thoughts; recording people’s dreams; or allowing police to identify criminals by recalling the memories of a witness.

However, it could also herald a new Big Brother era, similar to that envisaged in the Hollywood film Minority Report, in which an individual’s private thoughts can be readily accessed by the authorities.

Jack Gallant and Shinji Nishimoto, two neurologists from the University of California, Berkeley, last year managed to correlate activity in the brain’s visual cortex with static images seen by the person. Last week they went one step further by revealing that it is possible to “decode” signals generated in the brain by moving scenes.

In an experiment which has yet to be peer reviewed, Gallant and Nishimoto, using functional magnetic resonance imaging (fMRI) technology, scanned the brains of two patients as they watched videos.

A computer programme was used to search for links between the configuration of shapes, colours and movements in the videos, and patterns of activity in the patients’ visual cortex.

It was later fed more than 200 days’ worth of YouTube internet clips and asked to predict which areas of the brain the clips would stimulate if people were watching them.

Finally, the software was used to monitor the two patients’ brains as they watched a new film and to reproduce what they were seeing based on their neural activity alone.

Remarkably, the computer programme was able to display continuous footage of the films they were watching — albeit with blurred images.

In one scene which featured the actor Steve Martin wearing a white shirt, the software recreated his rough shape and white torso but missed other details, such as his facial features.

Another scene, showing a plane flying towards the camera against a city skyline, was less successfully reproduced. The computer recreated the image of the skyline but omitted the plane altogether.

“Some scenes decode better than others,” said Gallant. “We can decode talking heads really well. But a camera panning quickly across a scene confuses the algorithm.

“You can use a device like this to do some pretty cool things. At the moment when you see something and want to describe it to someone you have to use words or draw it and it doesn’t work very well.

“You could use this technology to transmit the image to someone. It might be useful for artists or to allow you to recover an eyewitness’s memory of a crime.”

Such technology may not be confined to the here and now. Scientists at University College London have conducted separate tests that detect, with an accuracy of about 50%, memories recalled by patients.

The discoveries come amid a flurry of developments in the field of brain science. Researchers have also used scanning technology to measure academic ability, detect early signs of Alzheimer’s and other degenerative conditions, and even predict the decision a person is about to make before they are conscious of making it.

Such developments may have controversial ramifications. In Britain, fMRI scanning technology has been sold to multinational companies, such as Unilever and McDonald’s, enabling them to see how we subconsciously react to brands.

In America, security agencies are researching the use of brain scanners for interrogating prisoners, and Lockheed Martin, the US defense contractor, is reported to have studied the possibility of scanning brains at a distance.

This would allow an individual’s thoughts and anxieties to be examined without their knowledge in sensitive locations such as airports.

Russell Foster, a neuroscientist at Oxford University, said rapid advances in the field were raising ethical questions.

“It’s absolutely critical for scientists to inform the public about what we are doing so they can engage in the debate about how this knowledge should be used,” he said.

“It’s the age-old problem: knowledge is power and it can be used for both good and evil.”

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UK Gets a Taste of American Eavesdropping

October 16, 2008 Intelligence, privacy No Comments

Plans for a massive expansion of ‘Big Brother’ state surveillance to cover every phone call, email, text message and internet visit in Britain were unveiled yesterday.

nsa listeningUK Home Secretary Jacqui Smith claimed
that storing details of individuals’ communications was vital to prevent further terrorist atrocities.

Activities which will be subject to snooping for the first time include visits
to social networking sites such as Facebook, auction sites such as eBay, gaming websites and chatrooms.

Police and security services will not be
able to access the precise content but will know each site visited, and to whom and when a phone call, text message or email was sent.

If this sets alarm bells ringing, they could seek a Ministerial warrant to intercept exactly what is being sent, including the content.

The billions of pieces of data are likely
to be stored for a year or more. The cost
is estimated to be at least £1billion, and
could be far higher.

Last night MPs and privacy groups attacked the proposals as ‘Stalinist’, ‘Orwellian’ and a reversal of the presumption that a person is innocent until proven guilty.

One opponent said: ‘They are making us all suspects.’

A leaked memo written by sources close to the project revealed it was fraught with technical difficulties.

Officials are split between placing the vast amount of data to be collected on a huge central Government database or forcing service providers to store the information,
to be accessed on demand.

Currently, the option being worked on is to request data from the service providers, the memo reveals. They are likely to pass on extra costs to customers.

Shadow Home Secretary Dominic Grieve said: ‘These proposals would mark a substantial shift in the powers of the state to obtain personal information on individuals.

‘Given the Government’s poor record on protecting data and running databases there
needs to be a full and proper debate.

‘The public will also be acutely aware of how, under this Government, surveillance powers designed to combat terrorism and serious organised crime have been used by local authorities to investigate things like fly-tipping. This would be absolutely unacceptable.’

Liberal Democrat spokesman Chris Huhne said: ‘The Government’s Orwellian plans for a vast database of our private communications are deeply worrying.

‘Ministers claim the database will only be used in terrorist cases, but there is now a long list of cases from the arrest of Walter Wolfgang for heckling at a Labour conference to the freezing of Icelandic assets where anti-terrorism law has been
used for purposes for which it was not intended.

‘These proposals are incompatible with a free country and a free people.’

We’re watching you: An East German Stasi officer listens in on a couple in a scene from the Oscar-winning film The Lives Of Others. Jacqui Smith has unveiled plans for a massive expansion of state surveillance
Phil Booth, of the NO2ID privacy campaign, said: ‘This is the Stalinist vision which we always knew was on the agenda. Monitoring the entire population is a complete abhorrence, reversing the presumption of innocent until proven guilty and making us all suspects.’

But senior security and police services were adamant that, without the new powers, lives would be put at risk.

They said some investigations have already been affected by criminals who use technology to avoid detection, by plotting online through social networking sites or
interactive games.

‘Criminals are getting more sophisticated in using this technology and they are going to exploit it unless we do something,’ one source said.

Miss Smith yesterday admitted the public had reason to be concerned.

In a speech to the Institute for Public Policy Research thinktank, she said: ‘Of course, even if there had not been events [data losses], the British public would have every right to be sceptical about a state activity that involves the collection of data.’

But she said that, without increasing their capacity to store data, the police and security services would have to consider a ‘massive expansion of surveillance’.

And she insisted: ‘There are no plans for an enormous database which will contain the content of your emails, the texts that you send or the chats you have on the
phone or online.

‘Nor are we going to give local authorities the power to trawl through the database in the interests of investigating lower level criminality under the spurious cover
of counter-terrorist legislation.’
Source: Dailymail

See More: NSA Monitoring Capabilities

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Big Brother Extends Reach in U.K.

October 10, 2008 privacy 1 Comment

A new generation of speed cameras that can track drivers for up to 30 miles and cannot be dodged are being tested by police.

The devices stop motorists evading a ticket by braking suddenly before a camera and then speeding up immediately afterwards. The new cameras could cover whole areas of cities or suburban housing estates, guarding any number of entry and exit points.

By ‘talking’ to each other down phone or internet lines, they calculate a car’s average speed – even if it makes a series of left and right turns down a variety of roads.

The cameras are already in use, but mainly on the motorways.

They are now likely to appear on rural and urban roads, spelling the end for the 6,000 yellow ‘Gatso-style’ box cameras currently in use.

 

Transport minister Jim Fitzpatrick yesterday told a road safety conference that the latest cameras would be a key weapon in the fight to reduce road casualties.

Supporters say they are ‘fairer’, have so far reduced casualties by 50 per cent and encourage a smoother traffic flow and safer, more consistent driving behaviour.

But critics say it is merely a new chapter in the Government’s war on motorists, who paid £106million in fines last year.

One system, costing £200,000 to £1million depending on the size of the area covered, could replace many fixed-point speed cameras.

But although the number of cameras might reduce, greater areas of the road network would be covered.

One of the providers of average speed cameras, SPECs, told the conference that the cameras could be networked together, could be forward or rear facing, could scan multiple lanes and cover areas from 250 yards to nearly 30 miles.

The cameras photograph a number-plate as a vehicle enters the speed restriction zone, and then again when it leaves.

The system then calculates the car’s average speed between the two points.

If it is higher than the speed limit, the driver is automatically sent a fixed penalty fine and receives three points on their licence.

Mr Fitzpatrick said: ‘Trials have shown very good results. Wherever there are average speed camera signs, traffic moves at a uniform speed and crashes reduce.’

Approval for the new generation of cameras is imminent. It will be up to local authorities to decide whether to buy the system.

˜ Electronic signs that sense when a car is speeding and switch traffic lights further down the road to red, forcing it to stop, are to be introduced in Britain.

The system, already in use as a traffic calming measure in Spain, will be installed on Camden High Street in North London.

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RFID Fears and Myths

June 26, 2008 privacy 2 Comments

rfid chipIn an effort to dispel some of the privacy concerns surrounding radio frequency identification technology (RFID), the Information Technology Association of America has issued a white paper covering what the technology is and is not capable of.

The report “RFID Myths and Urban Legends,” available from the ITAA Web site, cites some of the benefits of the technology, including identity management, supply-chain efficiency, pharmaceutical tracking, food safety/recall, security, and stock control. RFID has the potential to have profound impact on industry.

As you know, RFID is an automated data-capture technology. The technology consists of RFID tags, RFID readers, and a data collection and management system. Because RFID can be used for personal identification, there are privacy and security concerns regarding the technology. The ITAA white paper is a useful resource to counter some of these concerns in your company by correcting misinformation:

* Companies and governments plan to track you using RFID.

Not true because an RFID tag has no awareness of geographical data. An RFID tag must be within 10 to 30 feet of a reader – outside of that range, tags don’t emit a signal. “Big Brother” type surveillance would require billions of readers and antennas within that range.

* RFID creates a database in the sky.

When it’s so difficult for companies to integrate their disparate sources of data, is it really realistic to believe there will be a single database that tracks all your purchases? RFID doesn’t change the way information is used or stored.

* RFID will spur drive-by reads.

RFID requires direct line of sight within the 10- to 30-foot range. It does not work through walls, so it’s highly unlikely someone could park at the curb to find out what’s in your medicine cabinet unless your lawn was dotted with readers.

* RFID can lead to identity theft.

The tags do not usually contain personally identifiable information. Rather, they transmit unique identifiers that function like license plates. You’d need access to a database that should be secured with encryption and all the other usual standard forms of protection.

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