- Email: [email protected]
CONDUCT OF RESEARCH ON AMRINONE
1462 3. Gould LC. Crime and the addict: Beyond common sense. In: Inciardi JA, Chambers CD, eds. Drugs and the criminal justice system. Beverly Hills, California: Sage, 1974. 4. Johnson BD, Goldstein PJ, Prebel E, et al. Taking care of business: the economics of crime by heroin abusers. New York: Halsted, 1985.
CONDUCT OF RESEARCH ON AMRINONE
SIR,-Dr Wilmshurst (Nov 29, p 1280) has written to you about
complaint he made to the Association of the British Pharmaceutical Industry (ABPI) about the conduct of one of our the
member companies, Sterling Winthrop. The ABPI Code of Practice was drawn up to deal solely with complaints related to marketing and promotional activities. It is not an appropriate vehicle for dealing with complaints about relations between a company’s research department and a clinical trial
investigator. The complaints were also made to the Department of Health and Social Security’s (DHSS) Medicines Division, who investigated the matter in the context of the legal powers vested in them. The ABPI were, therefore, inhibited from any investigation until the conclusion of the DHSS’s review of the complaints. The DHSS position was laid out in a reply by Mr Tony Newton, the Minister for Health, to questions from Mr Jack Ashley, and given on Dec 3. Wilmshurst had asked for an investigation of Sterling Winthrop for its actions on amrinone in January, 1983, October, 1984, and February, 1985; and the DHSS mounted full investigations in 1983 and in 1985 to see if the company was in breach of the Medicines Act 1968 or other legislation. In his reply the Minister wrote: "The Department took legal advice on the reports of these investigations but was advised that there was insufficient evidence to undertake a criminal prosecution. It was however clear that there had been confusion and misunderstanding between the company and the doctors at St Thomas’ about the basis of the clinical trials at the hospital. The company was given strict instructions regarding the improvements of these procedures in such trials, including the need for adequate communication with medical investigators, involved in a clinical trial, to ensure that they understand fully the situation. The company has undertaken to comply fully in future with all legal requirements." The complainant was told in general terms of the outcome of both investigations. On Aug 30, 1985, he sought a further investigation. In his reply of Nov 4, 1985, the Parliamentary Under Secretary of State for Health, Mr Ray Whitney, wrote that "The Department was concerned about the lack of understanding by all participants in these cases about the responsibilities of those involved with clinical trials". Noting that a further letter dated Nov 4, 1986, was being studied the Minister in his Parliamentary reply of Dec 3 stated: "It is not correct to suggest, as some have done, that the Department is unable to act against any pharmaceutical company which threatened doctors or acted fraudulently. Where the evidence justifies it, we would not hesitate to use all available powers either under the Medicines Act or the general criminal law." The ABPI began their own detailed investigations, under the Rules of the Constitution of the Association, after the DHSS had indicated that it was not going to pursue the matter further. The ABPI concluded: "there were failings on the part of both parties in the conduct of the clinical research" and that "The company has confirmed that it has adopted new standard operating procedures with regard to the conduct of clinical research which it is confident will prevent any repetition of the problems that have arisen in this case". The ABPI accepted that the company has taken reasonable steps to avoid the problems that arose and agreed with the consultant in charge of the research "that no useful purpose will be served in pursuing the matter any further". ABPI never applied pressure for the newspaper article to be dropped. It did, however, discuss the matter with the consultant in charge of the study and we did remark that public disclosure of the shortcomings of both parties in this dispute would not bring credit on the medical profession or the company. Such indeed has proved to be the case.
DEATH OF A CHILD IN AFRICA
SiR,—Icannot agree with Dr Savage’s remark (Nov 22, p 1209) that "a baby is worth nothing" to the African mother. Certainly, in an environment in which poverty, misery, and disease reign supreme the health and social services are inadequate and ineffective, it is not unusual for a mother to perceive her child’s death as almost an "unavoidable act of fate" as she helplessly watches the child pass away. Millions of African, Asian, and Latin American children die before concrete emotional attachments are formed with their mothers, and many families so bereaved are reasonably assured of replacements through a high fecundity. Moreover, the resources invested in these children by the time of their death and the economic impact of their demise on the family are very small. Nevertheless, the death of a child is a very painful event which many African mothers have come to expect, as part of the psychological preparation for motherhood. They are thus able (with the moral support given by members of the traditional extended family) to handle grief quite easily. What appears as callous indifference to the casual observer is no more than a rational appraisal of, and a complex emotional adaptation to, the prevailing sociocultural, economic, and environmental conditions. Health Services Management University of Manchester, Manchester M13 9PL
Unit,
IBUKUN-OLUWA O. OGUNBEKUN
POST-PARTUM HAEMORRHAGE IS ASSOCIATED WITH POOR HOUSING, NOT MULTIPARITY, IN BOTSWANA is usually associated uterine atony. In Western countries atonic haemorrhage is correlated with multiparity’-3 but in developing countries multiparity may not be the most important cause of PPH. At the Princess Marina Hospital, Gaborone, the referral centre for the whole of Botswana, all pregnant women are invited to attend the antenatal clinics, and most do usually at around 22 weeks’ gestation. One midwife looks after several women, which results in variation in the timing of administration of oxytoxic drugs in the third stage of labour. Most patients have an episiotomy. Unless there are complications women are discharged with their babies within 24 hours of delivery. We have reviewed the records of 2000 consecutive patients delivered at the hospital during March to September, 1985, to look for relationships between PPH (blood loss of 500 ml or more within 24 h of delivery) and parity or housing conditions. Parity was not recorded in 251 cases. In Gaborone most housing can be designated medium or low cost, and the distribution is predominantly geographical so the patient’s housing was classified by postal addresses. The records of 325 women from rural areas and 300 whose addresses were not recorded were analysed
SiR,—Post-partum haemorrhage (PPH)
with
trauma
or
separately. There
was no
relation between PPH and parity (table I) but women with low-cost housing was
frequency of PPH in
TABLE I-PPH AND PARITY*
I
I
*Not recorded in 251
TABLE II-HOUSING STANDARD AND PPH
Association of the British Pharmaceutical Industry, 12
Whitehall,
London SW1A 2DY
J. P. GRIFFIN, Director
I
cases.
*p = 0 02 (Armitage standardised normal deviate U test)
CONDUCT OF RESEARCH ON AMRINONE
SIR,-Dr Wilmshurst (Nov 29, p 1280) has written to you about
complaint he made to the Association of the British Pharmaceutical Industry (ABPI) about the conduct of one of our the
member companies, Sterling Winthrop. The ABPI Code of Practice was drawn up to deal solely with complaints related to marketing and promotional activities. It is not an appropriate vehicle for dealing with complaints about relations between a company’s research department and a clinical trial
investigator. The complaints were also made to the Department of Health and Social Security’s (DHSS) Medicines Division, who investigated the matter in the context of the legal powers vested in them. The ABPI were, therefore, inhibited from any investigation until the conclusion of the DHSS’s review of the complaints. The DHSS position was laid out in a reply by Mr Tony Newton, the Minister for Health, to questions from Mr Jack Ashley, and given on Dec 3. Wilmshurst had asked for an investigation of Sterling Winthrop for its actions on amrinone in January, 1983, October, 1984, and February, 1985; and the DHSS mounted full investigations in 1983 and in 1985 to see if the company was in breach of the Medicines Act 1968 or other legislation. In his reply the Minister wrote: "The Department took legal advice on the reports of these investigations but was advised that there was insufficient evidence to undertake a criminal prosecution. It was however clear that there had been confusion and misunderstanding between the company and the doctors at St Thomas’ about the basis of the clinical trials at the hospital. The company was given strict instructions regarding the improvements of these procedures in such trials, including the need for adequate communication with medical investigators, involved in a clinical trial, to ensure that they understand fully the situation. The company has undertaken to comply fully in future with all legal requirements." The complainant was told in general terms of the outcome of both investigations. On Aug 30, 1985, he sought a further investigation. In his reply of Nov 4, 1985, the Parliamentary Under Secretary of State for Health, Mr Ray Whitney, wrote that "The Department was concerned about the lack of understanding by all participants in these cases about the responsibilities of those involved with clinical trials". Noting that a further letter dated Nov 4, 1986, was being studied the Minister in his Parliamentary reply of Dec 3 stated: "It is not correct to suggest, as some have done, that the Department is unable to act against any pharmaceutical company which threatened doctors or acted fraudulently. Where the evidence justifies it, we would not hesitate to use all available powers either under the Medicines Act or the general criminal law." The ABPI began their own detailed investigations, under the Rules of the Constitution of the Association, after the DHSS had indicated that it was not going to pursue the matter further. The ABPI concluded: "there were failings on the part of both parties in the conduct of the clinical research" and that "The company has confirmed that it has adopted new standard operating procedures with regard to the conduct of clinical research which it is confident will prevent any repetition of the problems that have arisen in this case". The ABPI accepted that the company has taken reasonable steps to avoid the problems that arose and agreed with the consultant in charge of the research "that no useful purpose will be served in pursuing the matter any further". ABPI never applied pressure for the newspaper article to be dropped. It did, however, discuss the matter with the consultant in charge of the study and we did remark that public disclosure of the shortcomings of both parties in this dispute would not bring credit on the medical profession or the company. Such indeed has proved to be the case.
DEATH OF A CHILD IN AFRICA
SiR,—Icannot agree with Dr Savage’s remark (Nov 22, p 1209) that "a baby is worth nothing" to the African mother. Certainly, in an environment in which poverty, misery, and disease reign supreme the health and social services are inadequate and ineffective, it is not unusual for a mother to perceive her child’s death as almost an "unavoidable act of fate" as she helplessly watches the child pass away. Millions of African, Asian, and Latin American children die before concrete emotional attachments are formed with their mothers, and many families so bereaved are reasonably assured of replacements through a high fecundity. Moreover, the resources invested in these children by the time of their death and the economic impact of their demise on the family are very small. Nevertheless, the death of a child is a very painful event which many African mothers have come to expect, as part of the psychological preparation for motherhood. They are thus able (with the moral support given by members of the traditional extended family) to handle grief quite easily. What appears as callous indifference to the casual observer is no more than a rational appraisal of, and a complex emotional adaptation to, the prevailing sociocultural, economic, and environmental conditions. Health Services Management University of Manchester, Manchester M13 9PL
Unit,
IBUKUN-OLUWA O. OGUNBEKUN
POST-PARTUM HAEMORRHAGE IS ASSOCIATED WITH POOR HOUSING, NOT MULTIPARITY, IN BOTSWANA is usually associated uterine atony. In Western countries atonic haemorrhage is correlated with multiparity’-3 but in developing countries multiparity may not be the most important cause of PPH. At the Princess Marina Hospital, Gaborone, the referral centre for the whole of Botswana, all pregnant women are invited to attend the antenatal clinics, and most do usually at around 22 weeks’ gestation. One midwife looks after several women, which results in variation in the timing of administration of oxytoxic drugs in the third stage of labour. Most patients have an episiotomy. Unless there are complications women are discharged with their babies within 24 hours of delivery. We have reviewed the records of 2000 consecutive patients delivered at the hospital during March to September, 1985, to look for relationships between PPH (blood loss of 500 ml or more within 24 h of delivery) and parity or housing conditions. Parity was not recorded in 251 cases. In Gaborone most housing can be designated medium or low cost, and the distribution is predominantly geographical so the patient’s housing was classified by postal addresses. The records of 325 women from rural areas and 300 whose addresses were not recorded were analysed
SiR,—Post-partum haemorrhage (PPH)
with
trauma
or
separately. There
was no
relation between PPH and parity (table I) but women with low-cost housing was
frequency of PPH in
TABLE I-PPH AND PARITY*
I
I
*Not recorded in 251
TABLE II-HOUSING STANDARD AND PPH
Association of the British Pharmaceutical Industry, 12
Whitehall,
London SW1A 2DY
J. P. GRIFFIN, Director
I
cases.
*p = 0 02 (Armitage standardised normal deviate U test)