The NHS Commissioning Board will be allowed to use patient data to enable CCGs to compare their performance against other commissioners.

The GPES Independent Advisory Group (IAG) has approved the use of the General Practice Extraction Service (GPES) for patient-anonymised data on demographics, diseases, events and referrals from GP systems.

The Commissioning Board said the data would be used by CCGs to analyse outcomes, compare data between different practices and to map lifestyle factors against public health estimates.

Although the Board is now free to cherry pick data on a monthly basis, the IAG has ruled the action is dependent on three conditions. The NHS CB must clearly define the purpose of data extraction; the BMA and RCCP should be involved in discussions around what data is used; and that the extraction of data will maintain patients’ rights at all times in line with the NHS Constitution.

Critics of the move have voiced concerns that patients will be unaware that private information will be used for purposes other than their care. Dr Paul Cundy, Chairman of the General Practitioner Committee IT subcommittee, called for a public campaign to raise awareness of the change in data protection.

His colleague, Dr Chaand Nagpaul, GPC’s lead negotiator on IT, also backed measures to raise understanding of what the changes mean for patients. “We need to be confident that the rights of the public are respected,” he said. “It is vital the public are fully aware that these extractions are taking place. It’s unlikely a website in itself will be enough.”

‘Licence to blog’ agent Maxine Vaccine focuses her telescopic sights on unreliable statistics and the dangers of passing them on.

Mark Twain, the patron saint of the anti-bullshit movement, said there were three kinds of deception: “There are lies. There are damned lies. And there are statistics.”

It’s not literally true that statistical data can mean whatever you want them to. After all, numbers are only numbers. But a number – regressing for a moment to my misspent student days, which I wasted in studying – is only a signifier, easily detached from its referent in the real world. Between the raw data and the qualitative conclusion lies a world of potential distortion.

For example, take this statement: 50% of NHS trusts are performing below the median standard. Shut them down, right! Except that in any set of values of a single variable, 50% are below the median value.

Try another one: 20% of company CEOs in a survey of the UK pharma industry said they wished they’d taken up kitten breeding instead. That’s a disturbing picture of the industry... but faintly less so if the 20% means one CEO out of five who answered a leading question on Facebook at 3 am, when he was alone in a hotel room and the minibar was empty.

Another problem with statistics is that they induce meaning-blindness in the audience. They sound so unquestionable, so ‘hard data’, that the possibility of their being poorly sourced, fictitious or just plain wrong doesn’t occur. So when David Cameron announced in 2010 that 50% of girls on housing estates were becoming mothers while in their teens, the power of the statistic stopped most of his listeners thinking about the plausibility of what they were hearing.

The next day, in some embarrassment, Cameron declared he’d been incorrectly briefed: the correct figure was 5%. But how did he not question it at the time? Perhaps he thought something along the lines of: Housing estates... single mothers... promiscuity... feral children... what do you expect? But more probably, he didn’t even process it that far. The weight of the number stifled its own meaning.

The pharmaceutical industry may be experiencing a faint sense of relief that the first medical shock story of 2012 concerns breast implants rather than drugs. But it’s the relief of a soldier who sees the next platoon drawing sniper fire rather than his own. There isn’t much comfort in it. Just remember that a couple of years ago, a certain global pharma corporation was charged with publishing a fake clinical journal in Australia in which its product was praised by non-existent clinicians. If true, that’s chutzpah on a cosmic scale.

Both cases come down to statistics. In the fake articles (if they existed), the holy writ of spreadsheets and pie charts made the lies invisible. And in the case of the PiP breast implants, where industrial-grade silicon intended for use as mattress filler was substituted for medical-grade silicon intended to make women look even better than their natural selves, the company’s marketing director told sales executives: “Sales are more important than what the shells are made of.” Why? Because the lies could be hidden in perfectly formed pyramids of data, safe, protected – until they ruptured and the whole structure collapsed.

Moody statistics (including misinterpreted or misrepresented data) are like counterfeit banknotes: bright and new, easy to fold, easy to spend, but they will come back to haunt you. So keep your facts straight... and keep your figures even straighter.

Note: the views of Maxine Vaccine are not necessarily those of Pharmaceutical Field.

The FDA has approved Calgary Scientific’s medical imaging device, ResolutionMD Mobile, as a mobile diagnostic app for use in the US.

The new technology gives physicians remote access to patient images and reports stored within any healthcare facility, enabling clinical diagnosis of the patient from any location.

Dr James A. Brink, Professor and Chair of the Department of Diagnostic Radiology at Yale University School of Medicine, said: “The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.”

The mobile app promises complete security and advanced capabilities through minimal bandwidth, even on 3/4G wireless. The technology also ensures that patient image data cannot be lost or stolen, and no highly sensitive or confidential patient data is ever retained on the device.

Dr Byron Osing, CEO and Chair of Calgary Scientific, said: “Lost or stolen patient data is a critical issue in the medical IT sector, with regular announcements of significant HIPAA compliance fines being levied and legal settlements in the tens of millions of dollars.”

“The FDA clearance of the ResolutionMD solution is a key strategic step forward for the Medical IT sector in enabling a high performance and secure ‘mHealth’ paradigm, as well as ensuring that vast regions of the world that are currently dependent upon wireless connectivity can now leapfrog directly into the realm of advanced medical solutions," added Dr Osing. 

Non-diagnostic versions of the app are already licensed under OEM agreements with global leaders in medical imaging and information technology.

The software has also been approved by Health Canada, has acquired the CE Mark for distribution in the EU, and is available on Apple iPhone and iPad devices. 

Calgary Scientific is a provider of accessible, advanced visualisation solutions in medical imaging and web, mobility and collaboration enablement technologies, used to help industries achieve secure access with their existing technology.

The FDA has issued its first draft guidance detailing how decisions are made during premarket approval applications (PMAs) of medical devices.

The document outlines that safety data and effectiveness data are initially gathered, weighing the benefits of the technology against the probable risks associated with the device.

The guidance intends to “provide more clarity to manufacturers” about the factors considered when reviewing a PMA, stated Jeffrey Shuren, Director of the FDA’s Center of Devices and Radiological Health.

Mr Shuren said that many factors must be taken into account, “as medical devices grow increasingly complex”.

For example, the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are already available are taken into account.

The guidance also proposes that FDA medical device reviewers use a worksheet to demonstrate how they make benefit-risk determinations.

In some cases, this worksheet could be made public post-approval to make the FDA's process even more transparent.

Visit the FDA website for more information.

NICE wants further information on Roche’s RoActemra (tocilizumab) for the treatment of systemic juvenile idiopathic arthritis (JIA) after failing to recommend it in draft guidance.

The Institute’s independent Appraisal Committee has requested a range of detailed information including comparison data to existing treatments and a revised model.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says more information is required so NICE can “fully assess the benefits that tocilizumab might provide”.

A public consultation has now been opened with responses welcomed until 1^st September.

The appraisal focused on young people aged two years and older with JIA where specific previous treatments have not produced an adequate response.

But NICE says further data is required on RoActemra when it’s used in treating systemic JIA where the individual’s condition has responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate. Information about joint damage for patients receiving RoActemra, including long-term follow-up, has also been requested.

The draft guidance also does not recommend the treatment where methotrexate has not yet been tried, but NSAIDs and systemic corticosteroids have already been used.

“In the meantime, we welcome comments from patients and their carers and families, and clinicians, as part of our public consultation on the Committee’s provisional recommendations,” said Professor Longson.