866
Letters
to
the Editor
EXPERIMENTATION ON CHILDREN
SIR,-Having spent thirty years in research, mainly investigating the normal newborn infant, I was delighted to read Dr Skegg’s article (Oct. 8, p. 754) telling us that harmless investigations with the consent of the ethical committee, the paediatrician in charge, and, above all, the mother are, in his view, legal. This is in stark contradiction to the Medical Research Council’s statement: "In the strict view of the not
law, parents and guardians of minors cangive consent on their behalf to any procedures which are of no par-
ticular benefit
to
them and which may carry
some
risk of harm."’
and the D.H.S.S. Legal Division’s view: "The position in law is that no parent or tender years is entitled to give consent to any for the benefit of the child."2
guardian of a child of procedure which is not
To me, even greater force is given to Dr Skegg’s argument because I had-the good fortune to attend a lecture by Prof. Gerald Dworkin, followed by the meeting of a study group at the Institute of Advanced Legal Studies on May 27, 1977, at which Professor Dworkin argued entirely in the same sense as Dr Skegg. No-one in the group, consisting largely of academic and practising lawyers, in any way challenged this view and one feels, therefore, that this, may I say sensible, attitude seems already to have considerable authority. Any such investigation must be closely safeguarded, and there is strength in the position from which I work-that as a physiologist I am not in clinical charge of the infants and their mothers. We must all deplore experimentation which masquerades as part of clinical care for it leads to dangerous intellectual dishonesty as well as dubious ethics. The M.R.C. position has implicitly encouraged this approach. I believe Sir Harold Himsworth saw this when he was secretary of the M.R.C. and the ruling I have quoted was introduced. May I crave a little extra space to honour the courage of the Wellcome Trustees who recently gave me a grant for research in the newborn which was explicitly concerned with the normal physiology of the normal infant. Normal physiology will ultimately-provide the baseline for all good neonatal care. Department of Physiology, London Hospital Medical College, London E1 2AD
K. W. CROSS
STOMACH CANCER IN ATOMIC-BOMB SURVIVORS
follow-up study of patients treated by X rays for ankylosing spondylitis, Court Brown and Do113 reported an increased mortality from stomach cancer. However, no consistent evidence of a radiation (neutrons and gamma rays) effect SIR,-In
a
stomach cancer in atomic-bomb survivors has hitherto been shown. The estimated radiation doses which have been used in the life-span study of the A.B.C.C.-J.N.I.H. (now reorganised as the Radiation Effects Research Foundation) can be classified by method of estimation and quality of shielding history. Selection, using such factors, of subjects who had been assigned more accurate doses, adds to Court Brown and Doll’s evidence that ionising radiation can induce cancer of the stomach in man. Death-certificate information was available for the selected 79 560 individuals in the life-span study sample for the period Oct. 1, 1950, to Sept. 30, 1973. When the expected number of deaths were calculated from age/sex specific rates for the entire on
Cumulative
city (Hiroshima and Nagasaki), the stanmortality ratio for stomach cancer rose steadily with increasing dose up to 200 rad and over in Hiroshima, a statistically significant increase being observed only at the highest dose group (34 deaths, 23.4 expected). For Nagasaki, however, a consistent increase in the stomach-cancer mortality with increasing dose was not observed, but in the very high dose range (500 rad and over) 10 deaths were observed while 2.6 deaths were expected. Although the excess of stomach-cancer deaths was not large enough to provide direct evidence for a causal sample
in each
dardised
relation between irradiation and cancer, the trend of stomachcancer mortality over time in Hiroshima was suggestive of a role for irradiation. The trend over time was analysed by the life-table method and the results are shown in the figure. Because results for the 10-99 rad group were almost the same as those for the 0-9 rad group, the results for 10-99 rad are not shown. The probability of death from stomach cancer did not differ greatly between the three exposure groups for about the first 10 years. After that the mortality for the 100-199 rad group began to move upwards. Some 5 years later, the probability of death for the 200 rad and over group began to increase sharply and quickly surpassed the mortality risk for the 100-199 rad group. In the BEIR report2 it was estimated that the mean dose to the stomach tissue of patients with spondylitis who were exposed to therapeutic X rays was in the range 250-500 rad. For an atomic-bomb survivor, the corresponding dose might be in the lethal range, perhaps 600 or more.3 This difference in the exposure dose may explain in part the weak effect of irradiation on stomach cancer in atomic-bomb survivors. In addition, because neutrons made an appreciable contribution to the exposure in Hiroshima (27%) in contrast to Nagasaki (2%) and because the relative biological effectiveness of neutrons (relative to gamma radiation) is greater than 1,1 the radiation effect in Nagasaki may be still weaker for a fixed dose level. This work 2. National
logical of the Medical Research Council 1962/63; p. 21. H.M. Office. 2. See Lancet, 1974, ii, 398. 3. Court Brown, W. M., Doll, R. Br. med. J. 1965, ii, 1327. 1.
Report
Stationery
probability of death from stomach cancer (Hiroshi.
ma).
was
done while K. N.
was a
National Cancer Institute
of Sciences—National Research Council. Repon of BioEffect of Ionising Radiation Committee. N.A.S.-N.R.C., Washing-
Academy
ton, D.C.,
1972.
3. Ker, G. D. Personal communication. 4. Jablon, S., Fujita, S., Fukushima, K., Ishimaru, T., Auxier, J. A. A.B.C.C. technical report 12-70, 1970.
Letters
to
the Editor
EXPERIMENTATION ON CHILDREN
SIR,-Having spent thirty years in research, mainly investigating the normal newborn infant, I was delighted to read Dr Skegg’s article (Oct. 8, p. 754) telling us that harmless investigations with the consent of the ethical committee, the paediatrician in charge, and, above all, the mother are, in his view, legal. This is in stark contradiction to the Medical Research Council’s statement: "In the strict view of the not
law, parents and guardians of minors cangive consent on their behalf to any procedures which are of no par-
ticular benefit
to
them and which may carry
some
risk of harm."’
and the D.H.S.S. Legal Division’s view: "The position in law is that no parent or tender years is entitled to give consent to any for the benefit of the child."2
guardian of a child of procedure which is not
To me, even greater force is given to Dr Skegg’s argument because I had-the good fortune to attend a lecture by Prof. Gerald Dworkin, followed by the meeting of a study group at the Institute of Advanced Legal Studies on May 27, 1977, at which Professor Dworkin argued entirely in the same sense as Dr Skegg. No-one in the group, consisting largely of academic and practising lawyers, in any way challenged this view and one feels, therefore, that this, may I say sensible, attitude seems already to have considerable authority. Any such investigation must be closely safeguarded, and there is strength in the position from which I work-that as a physiologist I am not in clinical charge of the infants and their mothers. We must all deplore experimentation which masquerades as part of clinical care for it leads to dangerous intellectual dishonesty as well as dubious ethics. The M.R.C. position has implicitly encouraged this approach. I believe Sir Harold Himsworth saw this when he was secretary of the M.R.C. and the ruling I have quoted was introduced. May I crave a little extra space to honour the courage of the Wellcome Trustees who recently gave me a grant for research in the newborn which was explicitly concerned with the normal physiology of the normal infant. Normal physiology will ultimately-provide the baseline for all good neonatal care. Department of Physiology, London Hospital Medical College, London E1 2AD
K. W. CROSS
STOMACH CANCER IN ATOMIC-BOMB SURVIVORS
follow-up study of patients treated by X rays for ankylosing spondylitis, Court Brown and Do113 reported an increased mortality from stomach cancer. However, no consistent evidence of a radiation (neutrons and gamma rays) effect SIR,-In
a
stomach cancer in atomic-bomb survivors has hitherto been shown. The estimated radiation doses which have been used in the life-span study of the A.B.C.C.-J.N.I.H. (now reorganised as the Radiation Effects Research Foundation) can be classified by method of estimation and quality of shielding history. Selection, using such factors, of subjects who had been assigned more accurate doses, adds to Court Brown and Doll’s evidence that ionising radiation can induce cancer of the stomach in man. Death-certificate information was available for the selected 79 560 individuals in the life-span study sample for the period Oct. 1, 1950, to Sept. 30, 1973. When the expected number of deaths were calculated from age/sex specific rates for the entire on
Cumulative
city (Hiroshima and Nagasaki), the stanmortality ratio for stomach cancer rose steadily with increasing dose up to 200 rad and over in Hiroshima, a statistically significant increase being observed only at the highest dose group (34 deaths, 23.4 expected). For Nagasaki, however, a consistent increase in the stomach-cancer mortality with increasing dose was not observed, but in the very high dose range (500 rad and over) 10 deaths were observed while 2.6 deaths were expected. Although the excess of stomach-cancer deaths was not large enough to provide direct evidence for a causal sample
in each
dardised
relation between irradiation and cancer, the trend of stomachcancer mortality over time in Hiroshima was suggestive of a role for irradiation. The trend over time was analysed by the life-table method and the results are shown in the figure. Because results for the 10-99 rad group were almost the same as those for the 0-9 rad group, the results for 10-99 rad are not shown. The probability of death from stomach cancer did not differ greatly between the three exposure groups for about the first 10 years. After that the mortality for the 100-199 rad group began to move upwards. Some 5 years later, the probability of death for the 200 rad and over group began to increase sharply and quickly surpassed the mortality risk for the 100-199 rad group. In the BEIR report2 it was estimated that the mean dose to the stomach tissue of patients with spondylitis who were exposed to therapeutic X rays was in the range 250-500 rad. For an atomic-bomb survivor, the corresponding dose might be in the lethal range, perhaps 600 or more.3 This difference in the exposure dose may explain in part the weak effect of irradiation on stomach cancer in atomic-bomb survivors. In addition, because neutrons made an appreciable contribution to the exposure in Hiroshima (27%) in contrast to Nagasaki (2%) and because the relative biological effectiveness of neutrons (relative to gamma radiation) is greater than 1,1 the radiation effect in Nagasaki may be still weaker for a fixed dose level. This work 2. National
logical of the Medical Research Council 1962/63; p. 21. H.M. Office. 2. See Lancet, 1974, ii, 398. 3. Court Brown, W. M., Doll, R. Br. med. J. 1965, ii, 1327. 1.
Report
Stationery
probability of death from stomach cancer (Hiroshi.
ma).
was
done while K. N.
was a
National Cancer Institute
of Sciences—National Research Council. Repon of BioEffect of Ionising Radiation Committee. N.A.S.-N.R.C., Washing-
Academy
ton, D.C.,
1972.
3. Ker, G. D. Personal communication. 4. Jablon, S., Fujita, S., Fukushima, K., Ishimaru, T., Auxier, J. A. A.B.C.C. technical report 12-70, 1970.
