272 Mad. Sci. Law (1992) Vol. 32, No.3
Letter to the Editor 26 February 1992 Sir, I read with considerable interest the article by A. Samuels, Informed Consent: The Law, (Med. Sci. Law 32, 35-42). He covers the clinical trial with regard to two assumed equivalent drugs, and also where there is an inferior drug. He also considers the volunteer. However, he fails to give consideration to the use of placebo. This surely is the ultimate in inferior medication and cannot necessarily be regarded as 'in the best interests of the patient'. He also mentions that any consent to such inferior treatment 'must be open to doubt'. I ask where that leaves those of us involved in the management or performance of placebo controlled clinical trials? Yours faithfully P J H Tooley, MBBS MRCGP DMJ Siplak House Station Road, Lower Shiplake Henley on Thames OXONRG93NY
Replyto Dr P. J. H. Tooleyfrom Alec Samuels 16 March 1992 Sir, The doctor must do the best for his patient. If that necessarily involves a drug, either definitely drug A, or drug B, then the placebo has no place. There cannot be inferior medication if what is administered, drug or placebo, is known or believed to be inferior. If it could be a drug or it could be nothing, i.e. placebo, then a clinical trial involving just the drug, or just the placebo, or both, would be perfectly proper and lawful, because there is no inferior medication; the purpose of the clinical trial itself is to try to establish which is superior and which inferior, i.e. drug or non-drug (placebo). A clinical trial is defined in the Medicines Act 1968 s.31, i.e. where there is evidence that medicinal products have effects which may be beneficial to the patient and the administration is for the purpose of
ascertaining whether, or to what extent, the products have those or any other effects, whether beneficial or harmful. A placebo is non-curative and pharmacologically inert or inactive, a non-drug, so administering it, with consent, where no drug is needed is perfectly proper and lawful. A person ought not to be damnified or prejudiced by participating in a clinical trial. He ought not to be misled - though he may consent to being in the trial, knowing it could be one thing or the other that he will get. If there is no known effective treatment, then placebos would be in order; they would appear to be no better and no worse than anything else. If the purpose of the clinical trial is to see whether something extra added to the established treatment (say drug A) would work, then, in addition to the established treatment, drug A, drug B and a placebo could be tried out, quite properly and lawfully. A placebo would be appropriate if the doctor were researching into symptoms, particularly subject symptoms, rather than seeking means of combating organic illness or disease. A psychological illness in a patient might indicate the administration of a placebo as part of bona rule medical treatment, but that is a different matter. A placebo would not be appropriate where the patient was in pain and needed a drug to cope with that pain - unless perhaps the doctor thought that the pain was psychological, or might be, and he wished, in the interests of the patient, to establish the truth of the matter. Experimentation can never be justified where it subjects the patient to unnecessary risk. And consent is required for all medical procedures. Alec Samuels
REFERENCES Mason J. K. and McCall Smith R. A. (1991) Law and Medical Ethics 3rd edition, Butterworths, pp. 357-8. Simmons B. (1978) Problems in deceptive medical procedures : An ethical and legal analysis of the administration of placebos. J. Med. Ethics 4, 172.
Letter to the Editor 26 February 1992 Sir, I read with considerable interest the article by A. Samuels, Informed Consent: The Law, (Med. Sci. Law 32, 35-42). He covers the clinical trial with regard to two assumed equivalent drugs, and also where there is an inferior drug. He also considers the volunteer. However, he fails to give consideration to the use of placebo. This surely is the ultimate in inferior medication and cannot necessarily be regarded as 'in the best interests of the patient'. He also mentions that any consent to such inferior treatment 'must be open to doubt'. I ask where that leaves those of us involved in the management or performance of placebo controlled clinical trials? Yours faithfully P J H Tooley, MBBS MRCGP DMJ Siplak House Station Road, Lower Shiplake Henley on Thames OXONRG93NY
Replyto Dr P. J. H. Tooleyfrom Alec Samuels 16 March 1992 Sir, The doctor must do the best for his patient. If that necessarily involves a drug, either definitely drug A, or drug B, then the placebo has no place. There cannot be inferior medication if what is administered, drug or placebo, is known or believed to be inferior. If it could be a drug or it could be nothing, i.e. placebo, then a clinical trial involving just the drug, or just the placebo, or both, would be perfectly proper and lawful, because there is no inferior medication; the purpose of the clinical trial itself is to try to establish which is superior and which inferior, i.e. drug or non-drug (placebo). A clinical trial is defined in the Medicines Act 1968 s.31, i.e. where there is evidence that medicinal products have effects which may be beneficial to the patient and the administration is for the purpose of
ascertaining whether, or to what extent, the products have those or any other effects, whether beneficial or harmful. A placebo is non-curative and pharmacologically inert or inactive, a non-drug, so administering it, with consent, where no drug is needed is perfectly proper and lawful. A person ought not to be damnified or prejudiced by participating in a clinical trial. He ought not to be misled - though he may consent to being in the trial, knowing it could be one thing or the other that he will get. If there is no known effective treatment, then placebos would be in order; they would appear to be no better and no worse than anything else. If the purpose of the clinical trial is to see whether something extra added to the established treatment (say drug A) would work, then, in addition to the established treatment, drug A, drug B and a placebo could be tried out, quite properly and lawfully. A placebo would be appropriate if the doctor were researching into symptoms, particularly subject symptoms, rather than seeking means of combating organic illness or disease. A psychological illness in a patient might indicate the administration of a placebo as part of bona rule medical treatment, but that is a different matter. A placebo would not be appropriate where the patient was in pain and needed a drug to cope with that pain - unless perhaps the doctor thought that the pain was psychological, or might be, and he wished, in the interests of the patient, to establish the truth of the matter. Experimentation can never be justified where it subjects the patient to unnecessary risk. And consent is required for all medical procedures. Alec Samuels
REFERENCES Mason J. K. and McCall Smith R. A. (1991) Law and Medical Ethics 3rd edition, Butterworths, pp. 357-8. Simmons B. (1978) Problems in deceptive medical procedures : An ethical and legal analysis of the administration of placebos. J. Med. Ethics 4, 172.
