On 2016 May 08, Amitav Banerjee commented:

The study by Deshmukh et al,[1] entitled, “Taken to Health Care Provider or Not, Under-Five Children Die of Preventable Causes: Findings from Cross-Sectional Survey and Social Autopsy in Rural India,” published in the current issue of Indian Journal of Community Medicine, raises some serious debatable issues which need to be revisited.

1. On the whole this cross sectional study, covering rural areas from 16 districts in 8 states of India to identify the causes of death among under-five children and health seeking behavior of caregivers by verbal autopsy, does not yield any novel information. No one with a basic understanding of public health in India would find surprising that mortality was mostly due to neonatal etiologies and preventable causes such as acute respiratory infections, diarrhea, and so on. The fact that most caregivers preferred private health care facilities over government health centers is also to be expected given the poor quality and availability of public health facilities in rural areas. Many studies have brought out these factors ad-nauseam.

2. This study would have passed as a benign redundant study but for the fact that it has raised a serious debatable issue by some very casual inferences which can misguide the reader, the policy makers and the lay public.

3. The issue concerns the authors’ claim that this study is the first study on Sudden Unexplained Deaths (SUDS). They found 1.4% (21 out of 1488) of deaths among under-five children otherwise healthy before death which they labeled as SUDS. Well, so far, so good. However, while discussing the implications of this finding vis-à-vis Adverse Effects Following Immunization (AEFI), one wonders why they drag in AEFI in their discussion since it was not one of the study objectives. Further, they also claim, naively, that no vaccination histories were available for these cases. So one would like to know by what stretch of imagination one can conclude, in either direction, the relationship between immunization and these cases of SUDS from the data they provide. Authors have resorted to speculation in absence of scientific reasoning.

4. They claim that the findings regarding SUDS in their study could serve as a baseline for future assessment of SUDS in Indian children and could be used for analysis and in contextualizing SUDS and AEFI deaths in India. Well, again, so far, so good. Now follows the gaffe.

5. The authors have made the following statement, “…SUDS and AEFI deaths in India …have been wrongly attributed to new vaccine in the lay press (here they have cited two references, 25 and 26).” This statement and the references labeled as “lay press” are very misleading. Reference number 25 (cited as “lay press”) is a very balanced editorial, published in the Indian Journal of Medical Ethics, a reputed journal indexed in PubMed and Scopus among others. Reference number 26 is “Weekly Epidemiological Record from WHO Geneva!!” One wonders whether the authors have read these references before citing them, otherwise they would not have made this blunder of labeling them as “lay press.”

6. One would strongly recommend all readers who read Deshmukh et al’s paper[1] to also read these references cited as “lay press” by the authors. Puliyel in his editorial in the Indian Journal of Medical Ethics,[2] has very elegantly with simple calculation (he resorted to all causes mortality since SUDS specific mortality was not available) demonstrated that unexplained deaths after introduction of pentavalent vaccine increased much beyond the base rate for all causes infant mortality rate in Kerala. If Deshmukh et al[1] suggest that data from their present study regarding SUDS be used to contextualize AEFI and SUDS then Puliyel’s caution about adverse effect of pentavalent vaccine becomes stronger as only 2.3% of all cause infant mortality would be expected as SUDS (and co-incidental to administration of pentavalent vaccine). While their data on SUDS supports Puliyel’s concerns about AEFI deaths after pentavalent vaccine (in fact more than Puliyel’s own editorial, since based on this data SUDS would be only a fraction of all causes infant mortality), they casually dismiss his editorial as “lay press.”

7. Similarly the other reference cited by the authors as “lay press”, i.e. The Weekly Epidemiological Record from WHO[3] cautions that in the context of evaluating a safety signal, it is important that countries understand their own infant mortality rates and underlying causes. If a particular serious AEFI is identified as a concern, additional epidemiological studies should be conducted to ascertain factors that can be used to evaluate the evidence for risk hypothesis. SUDS, among other causes of infant mortality, would benefit from detailed epidemiological studies. The report by WHO in this issue of the WER, concedes that there have been deaths following pentavalent vaccine in Sri Lanka, Bhutan, India and Vietnam leading to temporary suspension of vaccination in some countries. Albeit in the end the report concludes that pentavalent vaccine is to be considered safe. This perhaps may be due to lack of proper baseline data on SUDS and inadequate epidemiological investigations of AEFI.

8. Based on Deshmukh et al[1] findings on SUDS, the WHO may be persuaded to reconsider its position on safety of pentavalent vaccine. Lastly, we hope Deshmukh et al appreciate their contribution to understanding AEFI – they have raised the bar of vaccine safety – not realizing they have done so!!

References

1. Deshmukh V, Lahariya C, Krishnamurthy S, Das MK, Pandey RM, Arora NK. Taken to health care provider or not, under-five children die of preventable causes: Findings from cross-sectional survey and social autopsy in Rural India. Indian J Community Med 2016;41:108-19

2. Puliyel J. AEFI and the pentavalent vaccine: Looking for a composite picture. Indian J Med Ethics 2013;10:142-6.

3. Weekly epidemiological record. Geneva: World Health Organization 2013; 88: 301 – 12. .

Dr Amitav Banerjee, Professor Community Medicine, Dr DY Patil Medical College, Hospital and Research Centre, Pune, India

On 2016 May 08, Amitav Banerjee commented:

The study by Deshmukh et al,[1] entitled, “Taken to Health Care Provider or Not, Under-Five Children Die of Preventable Causes: Findings from Cross-Sectional Survey and Social Autopsy in Rural India,” published in the current issue of Indian Journal of Community Medicine, raises some serious debatable issues which need to be revisited.

1. On the whole this cross sectional study, covering rural areas from 16 districts in 8 states of India to identify the causes of death among under-five children and health seeking behavior of caregivers by verbal autopsy, does not yield any novel information. No one with a basic understanding of public health in India would find surprising that mortality was mostly due to neonatal etiologies and preventable causes such as acute respiratory infections, diarrhea, and so on. The fact that most caregivers preferred private health care facilities over government health centers is also to be expected given the poor quality and availability of public health facilities in rural areas. Many studies have brought out these factors ad-nauseam.

2. This study would have passed as a benign redundant study but for the fact that it has raised a serious debatable issue by some very casual inferences which can misguide the reader, the policy makers and the lay public.

3. The issue concerns the authors’ claim that this study is the first study on Sudden Unexplained Deaths (SUDS). They found 1.4% (21 out of 1488) of deaths among under-five children otherwise healthy before death which they labeled as SUDS. Well, so far, so good. However, while discussing the implications of this finding vis-à-vis Adverse Effects Following Immunization (AEFI), one wonders why they drag in AEFI in their discussion since it was not one of the study objectives. Further, they also claim, naively, that no vaccination histories were available for these cases. So one would like to know by what stretch of imagination one can conclude, in either direction, the relationship between immunization and these cases of SUDS from the data they provide. Authors have resorted to speculation in absence of scientific reasoning.

4. They claim that the findings regarding SUDS in their study could serve as a baseline for future assessment of SUDS in Indian children and could be used for analysis and in contextualizing SUDS and AEFI deaths in India. Well, again, so far, so good. Now follows the gaffe.

5. The authors have made the following statement, “…SUDS and AEFI deaths in India …have been wrongly attributed to new vaccine in the lay press (here they have cited two references, 25 and 26).” This statement and the references labeled as “lay press” are very misleading. Reference number 25 (cited as “lay press”) is a very balanced editorial, published in the Indian Journal of Medical Ethics, a reputed journal indexed in PubMed and Scopus among others. Reference number 26 is “Weekly Epidemiological Record from WHO Geneva!!” One wonders whether the authors have read these references before citing them, otherwise they would not have made this blunder of labeling them as “lay press.”

6. One would strongly recommend all readers who read Deshmukh et al’s paper[1] to also read these references cited as “lay press” by the authors. Puliyel in his editorial in the Indian Journal of Medical Ethics,[2] has very elegantly with simple calculation (he resorted to all causes mortality since SUDS specific mortality was not available) demonstrated that unexplained deaths after introduction of pentavalent vaccine increased much beyond the base rate for all causes infant mortality rate in Kerala. If Deshmukh et al[1] suggest that data from their present study regarding SUDS be used to contextualize AEFI and SUDS then Puliyel’s caution about adverse effect of pentavalent vaccine becomes stronger as only 2.3% of all cause infant mortality would be expected as SUDS (and co-incidental to administration of pentavalent vaccine). While their data on SUDS supports Puliyel’s concerns about AEFI deaths after pentavalent vaccine (in fact more than Puliyel’s own editorial, since based on this data SUDS would be only a fraction of all causes infant mortality), they casually dismiss his editorial as “lay press.”

7. Similarly the other reference cited by the authors as “lay press”, i.e. The Weekly Epidemiological Record from WHO[3] cautions that in the context of evaluating a safety signal, it is important that countries understand their own infant mortality rates and underlying causes. If a particular serious AEFI is identified as a concern, additional epidemiological studies should be conducted to ascertain factors that can be used to evaluate the evidence for risk hypothesis. SUDS, among other causes of infant mortality, would benefit from detailed epidemiological studies. The report by WHO in this issue of the WER, concedes that there have been deaths following pentavalent vaccine in Sri Lanka, Bhutan, India and Vietnam leading to temporary suspension of vaccination in some countries. Albeit in the end the report concludes that pentavalent vaccine is to be considered safe. This perhaps may be due to lack of proper baseline data on SUDS and inadequate epidemiological investigations of AEFI.

8. Based on Deshmukh et al[1] findings on SUDS, the WHO may be persuaded to reconsider its position on safety of pentavalent vaccine. Lastly, we hope Deshmukh et al appreciate their contribution to understanding AEFI – they have raised the bar of vaccine safety – not realizing they have done so!!

References

1. Deshmukh V, Lahariya C, Krishnamurthy S, Das MK, Pandey RM, Arora NK. Taken to health care provider or not, under-five children die of preventable causes: Findings from cross-sectional survey and social autopsy in Rural India. Indian J Community Med 2016;41:108-19

2. Puliyel J. AEFI and the pentavalent vaccine: Looking for a composite picture. Indian J Med Ethics 2013;10:142-6.

3. Weekly epidemiological record. Geneva: World Health Organization 2013; 88: 301 – 12. .

Dr Amitav Banerjee, Professor Community Medicine, Dr DY Patil Medical College, Hospital and Research Centre, Pune, India