Michelmores clinical negligence team report on disturbing disclosures over blood samples taken from unsuspecting haemophiliac patients.

Doctors at Royal Free Hospital in London carry out secret variant CJD blood test analysis without permission.

The Observer online news service reports today on the reaction of haemophiliac patients to the revelation that their blood samples were taken for secret blood tests for new variant CJD (the human form of "mad cow" disease) without their knowledge and consent. The secret blood testing had been revealed in the minutes of the meeting of the USA Food and Drug Administration (FDA) in 2006 which had been attended by a leading member of Britain's National Institute for Biological Standards Control. The secret samples were referred to by the British scientist as "a bit of serendipity" that could prove the "icing on the cake" for testing the development of an effective blood test for the disease.

The testing has been criticised by Professor Christine Lee, until recently head of the Royal Free hospital's haemophilia unit, who said that passing on blood samples without the knowledge or consent of patients raised serious ethical issues - particularly in the wake of controversies like the Alder Hey organ retention scandal. "You cant go around just grabbing stored samples", she said. Acknowledging that she had used samples for hepatitis and HIV infection research "at an earlier time" in her two decades at the Royal Free she said that attitudes had now changed: "You cant go ahead and test people without their knowledge. It's just not on". She said she had been shocked when she had learnt of the disclosure of the blood testing plan and has strongly urged both the Institute and her Royal Free successor Professor Edward Tuddingham to drop the initiative.

When contacted by The Observer Professor Tuddingham is quoted as saying "yes, we are in the process of transferring them (the blood samples) to the CJD surveillance group at the National Institute for Biological Standards Control. We still have them in the freezers here". He said the samples had been taken during testing for hepatitis C and HIV but he said those analyses were finished and the samples "were just going to be incinerated otherwise". "I got in touch because it occurred to me that the CHE people might be interested, and they were indeed extremely interested. So I was pleased to find a useful research end for the samples".

Patients are demanding that the blood testing be halted until they have been consulted. Long-time haemophiliac patient at the Royal Free Hospital, Mark Ward age 38 who contracted HIV from blood sourced from the USA had not been informed until the hospital had tested him for the virus without his knowledge. He said "Theyre doing the same to us as they did 20 years ago".

Mark Ward said that if asked he might have agreed to the release of his blood samples if it speeded up the development of the test for vCJD but to do so without informing him was "simply wrong ... we live in a world where we are supposed to have rights but I feel I am being treated like a laboratory rat".

Professor Christine Lee warned her successor at the Royal Free that even a plan to "anonymise" the samples was fraught with enormous patient counselling issues. She said that if indications of vCJD were found in any of the samples the question would arise of whether and how to inform the individual of the possible health risks to himself or others. She said the Royal Free's plan "has to come above the parapet. The patients have got to know about it - and give explicit permission".

To date 160 people in Britain have contracted variant CJD, including 4 transfusion patients who have either begun showing signs of the disease or were found to have symptoms following a post mortem. So far, no haemophiliac has developed the disease, but the Observer reports that concerns centre on the fact that two dozen batches of blood used for transfusion have included samples given by people who did go on to contract the disease.

Laurence Vick and paralegal researcher Michael Vian Clark act for a haemophiliac client in connection with litigation being contemplated in the UK courts following the dismissal of claims listed in the United States on a motion proposed by the Defendants blood product manufacturers. The motion was accepted on the grounds that proceedings in the UK will be more appropriate for UK Claimants. This ruling has left the haemophiliac litigants in limbo as lawyers consider solutions to legal or procedural obstacles to litigation in England and Wales.

Laurence Vick is a Clinical Negligence Solicitor and Partner at Michelmores Solicitors LLP http:medneg.michelmores. For more information and articles rabout medical claims, medical negligence and clinical negligence by this author, visit. medneg.michelmoresAdolescent Bipolar Symptoms
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