Concerns arise as the Union government contemplates reducing Hb cut-offs by 1.5 gm/dL. Experts formulate letter seeking to drop revision.
While three health experts have penned a critical note regarding the decision, there is also a signature campaign doing the rounds to request the Health Ministry and WHO to intervene. (Wikimedia Common)
India seems to be on the brink of a public health disaster as the government contemplates perilous changes to haemoglobin (Hb) cut-offs (used to determine anaemia) based on allegedly flawed research.
A controversial study by Sachdeva et al (2021), mentioned by two economists in a newspaper article, has triggered outrage among clinicians, activists, and public health experts who warn of the catastrophic consequences that could follow if the cut-off is lowered.
In response to this looming threat, a signature campaign has been launched, urging the Ministry of Health, the Indian Council for Medical Research (ICMR), World Health Organisation (WHO), and UNICEF to reject these changes before it’s too late.
To support the plea, three experts have provided a detailed critical analysis, highlighting the flaws in the statistical approach employed in the study, and outlining the potential far-reaching consequences that could arise from this perceived manipulation of numbers.
As per the WHO, anaemia is a condition in which the number of red blood cells or the haemoglobin concentration within them is lower than normal.
Haemoglobin (Hb) levels less than 12.0 g/dL in women and less than 13.0 g/dL in men is defined as anaemia.
Haemoglobin plays an important role by carrying oxygen and if there isn’t enough, there will be a decreased capacity of the blood to carry oxygen to the body’s tissues. This can result in symptoms like fatigue, dizziness, weakness, shortness of breath, etc. If untreated, it can lead to cardiac complications and adverse pregnancy outcomes.
Although iron deficiency is the most common cause for anaemia, many other nutrients such as good-quality proteins, vitamins A, C, E, B2, B6, B12, folate, magnesium, selenium, etc, are also vital to manufacture haemoglobin.
It all began when the Union government first decided to exclude questions related to anaemia from the National Family Health Survey (NFHS) 6 that is set to start from 6 July. They reasoned that the omission came after health experts questioned the efficacy of the method being used to estimate haemoglobin levels.
Paleness in the inner eyelids is a telltale sign of anaemia. (iStock)
According to Dr Sylvia Karpagam, a prominent public health activist specialising in food and nutrition, experts at the Ministry of Health and NITI Aayog have expressed concerns about the estimation by NFHS using capillary samples (blood drawn from a finger prick) and have suggested drawing samples from veins instead.
However, Dr Karpagam pointed out that this diagnostic method may pose challenges for lab technicians who would need to go around drawing samples from people’s veins during the surveys. This method of venous collection requires lab technicians, whereas surveys are done by trained researchers. We may not get enough lab technicians to cover the length and breadth of the country, so we will not get representative data for the country.
The Health Ministry has stated that it will be shifting this to the new Diet and Biomarkers Survey in India (DABS-I) that maps diet, nutrition, and health status. The ministry opines that this will provide a correct estimate of anaemia among the rural and urban populations.
However, this will not be as large a sample size as NFHS, therefore making state-level programmatic planning difficult, said Dr R Selvan, a paediatrician and researcher from Erode in Tamil Nadu.
Now, following this, economists Sanyal S and Dudani C (2023) published an article titled “Anaemia, a weak case” in the Economic Times on 13 April 2023 (the article is paywalled), seeking revision of anaemia prevalence rates, based on a research paper published in 2021 by Sachdeva et al.
This has irked public health experts, practicing clinicians, researchers, and all those who are working in the field of anaemia.
A detailed note critiquing the move and explaining the dangers of revising the haemoglobin cut-offs has been penned by Dr Karpagam, who is a researcher working on the Right to Health and Right to Nutrition in Karnataka, Dr Veena Shatrugna, a retired deputy director of National Institute of Nutrition in Hyderabad, and Siddharth K Joshi, a researcher and member of the Ahara Namma Hakku (Our Nutrition, Our Right) from Karnataka.
They argue that the paper by Sachdeva et al (2021), published in Lancet Global, suggests that India must move away from the WHO standards used to define haemoglobin cut-offs, which currently reveal an alarming anaemia prevalence of 40-65 percent in children, women, and even men in India.
The authors of the note said that “by reducing haemoglobin cut-offs by 1.5 gm/dL, as proposed by Sachdeva et al, the prevalence of anaemia would conveniently drop to less than 20 percent.”
The three experts questioned the need for this urgent revision of haemoglobin cut-offs.
“One would assume that the only group with a genuine interest in revising cut-offs would be clinicians or public health professionals. Have they articulated to the authors that the current cut-offs are adversely affecting their patient care and leading to poor quality care? In fact, the public health professionals have argued that lower cut-offs are contributing to issues of public health concern,” they noted.
Sachdeva’s study was based on the Comprehensive National Nutrition Survey (CNNS) that was conducted in India under the aegis of the Ministry of Health and Family Welfare in collaboration with UNICEF and the Population Council.
The CNNS study aimed to provide a nationally representative nutritional profile of preschoolers, school-age children, and adolescents in India.
The CNNS used a multistage, stratified sampling design to select a representative sample of households and individuals aged 0-19 years across all 29 states of India and the capital Delhi.
Participants were classified into three age groups: 0-4 years, 5-9 years, and 10-19 years. Individuals with chronic illnesses or ongoing acute illnesses were excluded from the survey.
Based on these CNNS findings, Sachdeva et al identifed a primary analytical sample of 8,087 individuals
from the larger CNNS sample of 49,486 individuals. Based on this analysis, Sachdeva et al revealed substantially lower haemoglobin cut-offs for diagnosing anaemia compared to the existing WHO cut-offs. The lower cut-offs were particularly prominent in children aged 1-2 years and girls aged 10 years or older.
When applied to their sample, the study’s cut-offs resulted in a lower prevalence of anaemia throughout the age range of 1-19 years, compared to the prevalence derived from WHO cut-offs.
The study’s results suggested that this finding has important implications for India’s approach to diagnosing and addressing anaemia.
The lower cut-offs identified in the study claimed that this provides a more accurate reflection of the anaemia burden in the country and are likely to lead to more effective public health interventions.
The study also highlighted the need for a re-evaluation of the one-size-fits-all definition of anaemia and the issuance of updated guidelines by WHO.
The study’s authors recommended that India adopts these lower haemoglobin cut-offs for diagnosing anaemia and suggested the use of haemoglobin centile curves to prevent misclassification errors.
Clinicians — especially paediatricians and obstetricians — nutritionists, activists, and public health professionals have objected to the study and expressed serious concern over some flaws.
The authors of the note critiquing the study said, “In order for a study to be applicable to an entire country, anaemia cut-offs, by definition, have to be arrived at based on haemoglobin levels of ‘healthy’ populations with no social, economic or nutritional constraints to hemoglobin synthesis.”
This means that the methodology should yield a study population that has access to all the macro and micronutrients necessary for haemoglobin synthesis. The population should be identified using clearly defined inclusion and exclusion criteria. A sub-sample from a survey such as CNNS cannot be used to set standards.
Explaining further to South First, Dr Selvan said that the purpose of any paper or any research should be to help the community.
Foods that can help in reducing anaemia. (iStock)
“Anaemia is a really difficult problem in India. In my own practice at our super-speciality hospital, I still see 30-40 percent of children with anaemia. All research papers, NFHS studies done so far has shown it increasing year by year in almost all places. It is mainly affecting growing children, adolescents, young women, mothers, pregnant women, and adult males too. Isn’t this the reason why the government is introducing intervention methods, even the controversial fortification of rice, Anaemia Mukt Bharat, etc?”
So, does the government want Anaemia Mukt Bharat by cutting down the haemoglobin values, Dr Selvan questioned.
He explained that the study itself mentions limitations and quite concerning ones at that.
The biggest limitation the study mentions is that its stringent exclusion criteria resulted in a loss of 80 percent of the sample. It argues that “this loss is within the range observed in similar studies, it should be considered when interpreting the results”.
However, according to Dr Selvan, this means that, “the study is based only on the 20 percent of the data? This shows how flawed it is and all the more reason for the Indian government to not base their decisions on this flawed study with no good data”, he stated.
Meanwhile, the study could also not evaluate certain haematopoietic nutrient deficiencies such as thiamine, pyridoxine, and copper. Also, the survey study design did not include infants aged 0–12 months, which limits the generalisability of the findings to this age group.
It is also shockingly excludes pregnant adolescents, given that teenage pregnancies and anaemia are a huge concern in this group.
Furthermore, it did not measure chronic inflammation through serum α1-acid glycoprotein or evaluate iron stores in detail, as well as other physiological factors, such as body composition and physical activity levels, which can influence haemoglobin concentrations, were not extensively evaluated in the study, argued Dr Selvan.
He said that to obtain a healthy population, the paper published excluded participants with serum iron, folate, vitamin B12, and retinol deficiencies, as well as inflammation, variant hemoglobins, and history of smoking.
Dr Sylvia Karpagam stated that anaemia has serious clinical consequences, especially in pregnancy, which includes heavy bleeding during and after childbirth, even resulting in the death of the mother or child or both. Some 20-30 percent of all causes of maternal mortality can be traced to anaemia.
“So, any decision regarding the cut-off can only be made with an assessment of clinical impact and definitely not by looking only at datasets,” she argued.
Also, the authors critiquing the study explained in their note: “It is significant that the researchers have relied completely on biochemical indicators rather than the nutritional (height, weight, dietary intake, serum protein… to name a few), socio-economic, and other constraints to haemoglobin synthesis.”
They said that the haemoglobin levels of this “healthy” population were compared with WHO thresholds and were found to be lower throughout 1-19 years population, usually by 1-2 gm/dL.
Interestingly, the CNNS itself has warned in its report that the survey was cross-sectional and provides information on the associations between indicators and outcomes, and cannot be used to conduct analysis of causality.
“Further, they say that disaggregated analysis by, for example, socio-economic status of CNNS biochemical indicators cannot be done even at the state level and only valid at the national level due to limitations in sample size,” the authors argued.
The CNNS survey focused on a vulnerable and disadvantaged population. Public health experts argue that with a high percentage of mothers lacking education and low rates of children receiving a minimum acceptable diet, the survey’s findings will represent a broader population but cannot be used to define cut-offs.
Rural areas are more affect by anaemia. (Wikimedia Commons)
Discrepancies in the consumption of iron-rich foods based on religion further question the selection of a “healthy” population for establishing cut-offs. Methodological flaws, such as the use of the frequency method in diet surveys, and the exclusion of children with nutritional deficiencies, add to the concerns.
Dr Selvan explained that for a survey, studying anaemia in rural or undernutrition populations is essential, but to devise a cut-off of anaemia it is important to study a healthy population.
Voicing a similar opinion, Dr Karpagam told South First, “Cut-offs have to be devised in healthy populations because it sets the standards of what we can achieve if we have no constraints to good nutrition. Currently, anaemia is a public health problem in India and this data is available to us through the National Family Health Survey. Measuring this helps us plan resources and also understand the cause for some other morbidity and mortality such as pregnancy complications and heart disease.
“It also helps us to identify preventive strategies through school health checks, supplementation with food, early diagnosis, treatment and referral,” noted Dr Sylvia.
Lowering the haemoglobin cut-offs based on flawed research poses several significant problems that cannot be overlooked, argue experts. They say that it undermines the severity of the anaemia crisis in India, a critical public health issue affecting a large population, particularly vulnerable groups such as women and children.
Dr Sanjay Kumar, a practicing clinician from Bengaluru, emphasised, “Reducing the cut-offs artificially lowers the prevalence figures without addressing the actual problem. It’s a deceptive approach that could hamper effective interventions.”
Anaemia can result in serious health complications. (iStock)
Moreover, relying on a narrow data set from the Comprehensive National Nutrition Survey (CNNS) 2019, which represents a population struggling with poverty, malnutrition, and limited access to education, paints an inaccurate picture.
Dr Poornima RS, paediatrician from Andhra Pradesh asserted, “Standards must be generated from a study of populations without growth constraints, ensuring access to quality food, education, and all socio-economic attributes for a healthy population.”
Implementing these changes without considering the ground realities and the long-term impact on public health could be catastrophic, noted Dr Sylvia. She added that lowering the cut-offs would result in a false sense of improvement,
disguising the true magnitude of the anaemia crisis.
She told South First, “We must not ignore the fact that anaemia has severe health consequences. Lowering cut-offs may lead to delayed interventions, causing long-term health complications and an increased burden on the healthcare system.”
Furthermore, diluting haemoglobin standards based on flawed research undermines the credibility of India’s progress in addressing anaemia. It sends a misleading message to international organisations and inhibits collaboration for effective interventions, Dr Sylvia stated.
The authors of the note opine, “We need accurate data to create evidence-based policies and interventions. The government’s reliance on unreliable research undermines the trust of the scientific community and jeopardizes progress in addressing anaemia.”
Recognising the potential dangers and pitfalls of implementing these changes, concerned individuals and organisations are demanding immediate action. The goal is to prevent the long-term consequences of misguided decisions and to protect the health and well-being of the population.
“Lowering the haemoglobin cut-offs means that women with a haemoglobin level of 9.5 gm/dL will come under the ‘Normal’ category, and the percentage of people with anaemia will come to less than 20 percent. It sounds like a miracle achieved with no effort, except their ability to re-define a normal population and calculate a large data set, just from one country — India,” stated the endorsement letter of the signature campaign.
The signature campaign is said to have got signatures from various people, including clinicians, researchers, nutritionists, public health experts, medical officers from the government departments too.
The last date to sign the endorsement is Thursday, 15 June, before 5 pm. The endorsements will be forwarded with the critique to the Ministry of Health, ICMR, WHO, and UNICEF.
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