Call to use Spine to find drug trial patients

Tags: CfH Confidentiality Database Drug

19 Feb 2007

The BioIndustry Association has expressed an interest in tapping into the NHS's Spine database and using patient information to identify potentially willing drug test subjects.

Speaking to the Scotsman, the association’s chief executive, Aisling Burnand said: “The UK has a real opportunity because the NHS's patient records make this a unique place in the world to study clinical trends. We are not there yet, but that is the vision.”

A BioIndustry Association spokesperson told E-Health Insider that Burnand was responding to suggestions made in the Cooksey Review into UK health research funding last December, and that other research organisations would hold similar interests.

In his foreword to the review, Sir David Cooksey, said: “The potential offered by the new ‘Connecting for Health’ IT database which will contain the medical records of the 8m inhabitants of England and should be accessible (with strong patient confidentiality safeguards) for important research, including clinical trials and subsequent pharmaco-vigilance studies of newly released drugs. In addition, there are the opportunities offered by the development of biomarkers and the emerging research into stem cell therapies.

“Combined with the reorganisation of the NHS R&D function to make it more accessible and transparent for industry, this opens the door for the UK to excel again in healthcare innovation and service delivery. The Review sets out to describe how this can be delivered. It is a once in a generation opportunity to do so and for Britain to take a leading position in a major sector of the knowledge based economy.”

The review recommended the establishment of a pilot programme, under the joint auspices of the NHS SDO (Service, Delivery and Organisation) programme and the NHS’ Connecting for Health ‘National Knowledge Service’, to examine the effectiveness of employing a small number of full-time ‘Knowledge Transfer Champions’, whose job would be to disseminate the findings of health services research and facilitate early adoption of those findings into routine practice in the NHS.

It re-iterated that Connecting for Health was established in 2005 to enhance Knowledge Reception and Use in the NHS via the National Programme for Information Technology (NPfIT).

“The National Programme for Information Technology, operated by NHS Connecting for Health, may be an important first step in the evolution of decision-based software systems that healthcare professionals will need in order to manage effectively the growing scale of our knowledge base and thus improve the care of patients. However, this programme is not likely to be operational at such a level for some time. Nor has it been designed specifically for the purpose of knowledge transfer.

“In any event, the uptake of new knowledge, particularly complex information, often depends the direct communication of new potential users with those familiar with that new technology, so that solutions involving information technology are unlikely to be entirely sufficient. Likewise, direct marketing or information campaigns are unlikely to adequately support the spread of these types of knowledge within the health services.”

The BioIndustry Association spokesperson told EHI that CfH have been working with the UK Clinical Research Collaboration to ensure that the Spine does have a strong research component, but discussions relating to usage of any data stored will need to wait until progress has been made on delivering the system.

Connecting for Health’s director of clinical knowledge, process and safety, Sir Muir Gray said: “There are still major problems in implementing best current evidence and I am in discussion with the producers of research evidence to discuss ways in which their outputs could be much more easily and quickly put into practice.”

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Links

Cooksey review http://www.hm-treasury.gov.uk/media/56F/62/pbr06_cooksey_final_report_636.pdf

BioIndustry Association http://www.bioindustry.org/

National Knowledge Service http://www.nks.nhs.uk/

Reader's Comments

the list just does on and on.....

stressfreedave@hotmail.com

19 Feb 07 13:02

Another fine example of why the spine is a bad idea. As if all doctors/nurses, SUS and loads of others wanting accesswas not bad enough, now this lot have decided they want access. Soon it will be a case of it will be easier to say who can't acccess the spine as the list will be far shorter.

What they going to do to protect patient confidentality? Get people to sign a bit of [a[er saying they wioll not tell people, then access it?

Access concerns

19 Feb 07 14:02

I share the worries of the previous poster (and envy his email address!) What happened to the Caldicott and Data Protection principles that data should only be used for the purpose for which it was originally collected, ie to manage the care of the patient?

Another twist in the saga ...

19 Feb 07 15:02

So - without having yet sorted out access controls for NHS clinical professionals - CfH is *already* working with the UK Clinical Research Collaboration to lay the groundwork for use of spine data in research.

Any other ongoing collaborations we maybe ought to know about? Interpol? The CIA?

The hand of industry...

19 Feb 07 17:02

This must not be allowed to happen!

Whilst I would (grudgingly) agree to data being used for public health purposes - incidence of disease in the population etc. it must never be allowed to be used for research involving 'Big Pharma'. What next, a letter through the door saying "we see you have high cholesterol, ask your doctor for a supply of Whizzostatin, and all will be well"?

I hope the researchers who are calling for this are held to account by their professional bodies. I know mine wouldn't hesitate were I to scan patient records for my research.

Patients' Interests?

19 Feb 07 19:02

Is there anyone out there who still believes that CfH is primarily to do with what's good for patients? All the features of CfH that could be good for patients (GP2GP transfer & a portable care record) can be achieved by much cheaper and currently available low technology solutions. The only reasons for maintaining CfH are nothing to do with patient care and everything to do with obtaining patient data, using it for the government's own purposes and selling it to large corporations.

PIAG

21 Feb 07 13:02

Permission to access medical records in any form (i.e. electronic or paper) is governed by Section 60 of the Health and Social Care Act.

For the Bioindustry Association to use the information in the Spine, it must either be anonymised, they have approval from PIAG (http://www.advisorybodies.doh.gov.uk/piag/) or a basis in law for the information.

In any case, the release is governed by the Care Record Guarantee (http://www.connectingforhealth.nhs.uk/news/crdb_guarantee).

There's no reason to get in a flap!

Couldn't we flog the data and cover NPfIT's costs?

Matthew.Grove@northumbria-healthcare.nhs.uk

23 Feb 07 15:02

I've been worried about this kind of use since the spine was first proposed.

Potentially, it has immense value. Want to know which statin really is best at reducing the incidence of MI? How about a study comparing every statin user in a population of almost 60,000,000 against their MI and CVA rate ... the power of such a database is incalculable.

It's so incalculable it's actually very very dangerous. Witness the recent Vioxx debacle and backlash against celecoxib, other NSAIDs et al ... this database (properly analysed) has the power to reliably answer all the questions being raised after such incidents. To the extent that Big Pharma is very, very vulnerable to the conclusions and company's share prices will be made or broken by the results.

On the positive side, if we (the nation) decided to sell the data commercially (anonymised of course) we should be able to cover the implementation costs of the whole caboodle ...

I also feel this is a very very bad idea. I'd really want to know who had access to the data, how it was anonymised, what questions they were asking, what the answers were, what their industry conflicts-of-interest are, etc etc.

PIAG

stressfreedave@hotmail.com

23 Feb 07 20:02

Relying on PIAG to protect data is a bit like relying on the DPA to protect medical data. Considering how usless the DPA is (the DPA allows the sharing of data not only without patient consent or knowledge but also where the patient has said no), the comparison is not good. Im sure I read that they were planning on doing away with PIAG, so who will decide about who has access? MPs?

PIAG have already given the go ahead to release identifiable medical data from GUM clinics and said that it would be acceptible for data about terminally ill patients to be released without witout informing/asking the patient. PIAG do not seem to know how many patients have had their identifiable data shared and dont seem to care.

Considering the amount of people that already have access to our sensitive data (I have been in practices where admin staff can find out about things like rape/abuse, sexual problems) the idea that Big Pharma will not get there hands on the data is hard to believe.

Then there is te fact that most people have never heard of PIAG or Section 60 of the Health and Social Care Act (I had to explain these to a GP who had never heard of any of it). Should us patients be forced to trust people who are unacountable for their actions and most people have nevere heard of and let them decide who can know what about us behind our backs?

I have already pointed out (EHI never seem to put this on the site) that researchers have already shown there is not a need for the data on SUS to be patient identifiable, therefore there would be no need for Big Pharma to get it.