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Medicine and the Law

Consent to medical treatment

In September, 1990, the UK Department of Healthissued the NHS management document Patient Consent toExamination or Treatment and A Guide to Consent forExamination or Treatment, which suggest that legalrequirements must be met for "valid consent" from patientsbefore treatment. One suggestion is that "where treatmentcarries substantial risks the patient must be advised of this bya doctor so that consent may be well-informed". Elsewhere,the documents state that "where a choice of treatment mightreasonably be offered the health professional may alwaysadvise the patient of his/her recommendations together withreasons for selecting a particular course of action".

Furthermore, it is suggested that sufficient informationmust normally be given to ensure that the patientunderstands the nature, consequences, and substantial risksand can thus take a decision on the basis of that information.These suggestions represent a major change in the law onconsent for medical treatment. The doctrine of informedconsent forms part of the law in some states of the USA, butin England and Wales the law has always been that patientshad to consent to treatment-and until 1985 that was all thelaw said on the subject. The Department of Health’s circularand accompanying guide suggest otherwise-that there areprecise rules. What is the truth?

In 1985 the House of Lords decided the case of Sidaway vBethlem Royal Hospital. Their lordships were dealing with thespecific question of whether a patient should be informed of all therisks of an operation for her consent to surgery to be valid. Theopposing position was that the amount of information given to apatient was a matter of professional judgment and that in some casesit would be wrong to volunteer any, let alone all, the risks of surgery.Such information might be given undue prominence by patients,most of whom would not be able to decide whether to accept therisk: thus to volunteer information would be to reduce the likelihoodthat the patient would consent to treatment which, in the clinician’sjudgment, the patient needed. These are diametrically opposedpositions, and a Government department’s advice on the matterwould be expected to follow the majority in the House of Lords.

Their lordships, by 4 to 1, rejected informed consent. LordBridge described it as "impractical". Lord Templeman stated thatthe doctor "bearing in mind the best interests of the patient andbearing in mind the patient’s right to information which will enablethe patient to make a balanced judgment, must decide whatinformation must be given to the patient and in what terms thatinformation should be couched." Lord Diplock, in similar vein, saidthat "To decide what risks the existence of which a patient should bevoluntarily warned and the terms in which such warning, if any,should be given, having regard to the effect that the warning mayhave, is as much an exercise of professional skill and judgment as anyother part of a doctor’s comprehensive duty of care to the individualpatient...". The judgment was clear: while the patient has a right torefuse treatment, it is a matter of professional judgment whatdoctors should tell the patient. In any litigation the courts should beguided by expert witnesses, as they are in other medical cases, as tothe amount of information which should be given. The doctrine ofinformed consent was specifically rejected, and forms no part of thelaw of England and Wales. The Department’s advice is, therefore,wrong in law.

The Department of Health seems to have arrived at thisposition by giving undue weight to some remarks made byLord Bridge, appearing to reserve to the judge the right toreject expert evidence on what a patient should have been

told. He spoke of a hypothetical case where there was asubstantial risk of grave adverse consequences (a 10% risk ofa stroke after an operation) and gave his opinion that in suchcircumstances a judge might conclude that no reasonablyprudent clinician would fail to disclose such a risk. Thisopinion by Lord Bridge is not an authoritative statement oflaw which we are bound to follow. He was in a minority;remarks about hypothetical cases (obiter dicta) are merelyasides, and the majority, including Lord Bridge, specificallyrejected the doctrine of informed consent or any absolutestandard of what patients should be told.

The Department’s advice is clearly wrong. We shouldanswer direct questions truthfully, and if we follow LordBridge and inform patients of substantial risks of graveadverse consequences, I am sure we would not be criticised.Most doctors would not hesitate to reveal a risk of 10% thatan operation would cause a stroke. Disclosure, however,remains a professional decision, and not one for the

Department of Health. Professional employees of theNational Health Service are not bound to comply withinstructions which require us to behave unprofessionally,such as putting patients at risk by giving them so muchinformation that they refuse necessary treatment. Theadvent of Crown indemnity does not alter this, since theemployer always was and remains vicariously liable for theactions properly taken by employees in the course of theiremployment. Doctors should reject this advice and theconsent forms which are based on it.

Ealing Hospital,Southall UB1 3HW, UK Christopher Heneghan

Noticeboard

From Bilharz to B cells

Theodor Maximilian Bilharz first described urinaryschistosomiasis in a Cairo morgue in 1852 and was later made

professor of zoology for his achievements. The disease has sincebeen identified in body tissues of Egyptian mummies as far back as1250 BC and now affects over 100 million people in Africa and theMiddle East. There is extensive damage to the whole length of theurinary tract during this chronic infection, including squamouscarcinoma of the bladder, despite host B and T cell responses thatlead to destruction of immature schistosomulae and so reduce wormload. The importance of immunological mechanisms in theclearance of parasites raises the possibility of vaccine developmentto control diseased Effective vaccine design depends on

understanding this host immune reaction to Schistosomahaematobium. What are the key events of the immune response tothese parasites?

It has been known for some time that IgE is produced in largequantities during an episode of schistosomiasis. IgE can mediatedamage to the parasite, but no evidence has been reported to suggesta function of IgE in host protection. However, in collaboration withcolleagues in the Gambia, UK workers now describe suchevidence.2 They found a peak frequency of S haematobium in thesecond decade of life and treated all patients with praziquantel.Reinfections were common and severe in children under 10 yearsbut uncommon and less severe in those over 15. The age-relateddecline in severity of reinfection suggested that protective immunityaccrued gradually over time. IgE concentrations were highest in theover-15 age group, and IgG4 concentrations were highest in 10-14year olds. Multiple logistic regression revealed that reinfection wassignificantly less likely in those with high IgE concentrations.Reinfection in patients in the lowest IgE quintile was ten times more