Medical Device Daily Contributing Writer

BARCELONA — April 16 is opening day for the UK's Biobank, a project of the National Health Service, in the hunt for 500,000 middle-aged volunteers to contribute blood and urine specimens for what will become the world's largest database linking individual genomic data to patient medical records.

More than 5 million UK citizens will receive an invitation to join the project by contributing the biomaterials, completing a 90-minute physical examination and interview during which they are asked to respond by touch-screen to 200 questions about health, lifestyle and family.

Biobank will progressively build a database toward the goal of connecting in late 2007 for the first time with individual medical records from the NHS, including both hospital and primary care documents.

A genomic analysis of each patient sample will then be added. The cross-referenced datasets are expected to yield 30 years of research into causes of diseases, individual patients' interactions with the British medical system and the effectiveness of therapeutics by pathology and genetic disposition.

"Half a million people is a pragmatic number because it is what we can afford," said Andy Harris, system architect with Biobank, at a press briefing during the World Health Care Congress Europe, late last month.

The only criterion is age, and the volunteers give their consent at six stages of the interview for a broad use of the data.

In exchange for the broad consent, the Biobank agrees to inform any patient if a significant disease association is found within his or her data. A detailed process will reverse the anonymity of records to make the patient aware of the problem.

For the recruitment campaign, Biobank is subject to strict constraints of the British Data Protection Act and has followed guidance of the Office of the Information Commissioner. The recruitment was given a green light after a review of procedures by the Patient Information Advisory Group.

Anything less than extreme security for the system is "not negotiable," said Steve Walker, chief information officer for UK Biobank. "We are not building an open multi-user system."

The briefing was sponsored by Oracle (Redwood Shores, California), which in 2005 won the task of building the data storage and communication systems using the Oracle Healthcare Transaction Base application. Up to 10 assessment centers will gather patient specimens and data for transmision to distributed regional centers, with central storage of the massively parallel datasets at both Oxford and Manchester. More than 20 universities are collaborating on the program.

The physical specimens will be stored in automated archives kept at -112 degrees Fahrenheit in a center in Manchester that is expected to use some 70 liters of liquid nitrogen a week.

Dr. Michael Thick, chief clinical officer for NHS's Connecting for Health IT program, told Medical Device Daily, "The promise of genetic prediction for health has been with us a long time. We are going forward to enter the world of 'omic' data with the goal of getting tighter, specific definitions from our patient population."

He added, "Pilots have shown that technologies can be deployed within a primary care setting, and that an enormously detailed profile of the patient can be produced very quickly." This capability, he said, "coupled with the clinical data, has great predictive and therapeutic power. It is not difficult to see that this could have a great impact on the overall health of the population and the costs of healthcare for the NHS."

Thick said the NHS team was inspired and convinced of the viability of the Biobank project after a visit to the Marshfield Clinic Research Foundation (Marshfield, Wisconsin). After breaking new ground in genetic research, in 2004 the Wisconsin group practice affiliated with the foundation began tracking 18,000 patients for a personalized medicine program that is America's largest population-based genetic research project

Personalized medicine creates the ability to deploy highly sophisticated testing to an individual and produce a specific list of probabilities of disease, drug susceptibilities and how both the disease and the drugs will react in that individual, Thick said.

The payoff of savings for the NHS, he said, includes patients being referred to appropriate specialties much earlier, delaying or avoiding progress into chronic disease, and avoiding the morbidity and cost of inappropriate drug treatment.

"It's important not to understate how important this development is," said Charles Scatchard, vice president of Oracle's EMEA Health Sector business. "Personalized medicine can significantly increase a patient's chances of survival. The only argument is, can we afford it?"

The personalization of medicine is the inevitable outcome of an e-health system where the use of services by an individual can be tracked both clinically and financially.

The UK Biobank extends the logic of e-health to an advance state beyond preventive programs to the ultimate application of predictive medicine.

Like the NHS's Connecting for Health effort, the German healthcare reform signed into law at the end of March also shifts responsibility for health toward the patient, not only recognizing the patient as the end-user of health services but enabling the patient to act as a direct consumer.

Dr. Hans J rgen Ahrens, chairman of AOK-Bundesverband (Bonn, Germany), Germany's largest group of regional health insurance funds, said, "Responsibility is often only considered as financial involvement of the patient, but it means more. It means taking on a personal responsibility for your actions and behaviors."

For this to work, "people need to be better informed in order to make their choice," Ahrens said. "We've seen that the personal situation of the patient improves if the patient feels better informed. We help promote their responsibility and the training we do is positive. Patients feel that they are being given something."

Cor Spreeuwenberg, dean of health sciences at the University of Maastricht (Masstricht, the Netherlands), agreed, saying, "the background assumption is that better-informed patients have better outcomes."

But he cautioned that the readiness of patients for self-management "is critical for success. An informed, activated patient supported by the health system and the community implies interaction at all levels."