Ahead of annual Haj pilgrimage, CDC warns of meningococcal infections in Saudi Arabia

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Ahead of annual Haj pilgrimage, CDC warns of meningococcal infections in Saudi Arabia

Haj happens only once a year. India has a quota of 1,75,025 pilgrims for Haj 2024

Weeks before thousands of people from across the world are all set to descend on Saudi Arabia for the annual Haj pilgrimage, the US Centers of Disease Control and Prevention (CDC) have warned physicians against the risk of meningococcal infections linked to that middle eastern nation. Haj is going to happen between June 14 and 19.

The emergency preparedness and response alert from CDC said that since April 2024, 12 cases of meningococcal disease linked to KSA (Kingdom of Saudi Arabia) travel for Umrah have been reported to national public health agencies in the United States (5 cases), France (4 cases), and the United Kingdom (3 cases). Two cases were in children aged ≤18 years, four cases were in adults aged 18–44 years, four cases were in adults aged 45–64 years, and two cases were in adults aged 65 years or older. Ten cases were in patients who traveled to KSA, and two were in patients who had close contact with travelers to KSA. Umrah is a pilgrimage that can happen round the year. Haj happens only once a year. India has a quota of 1,75,025 pilgrims for Haj 2024.

“Healthcare providers should work with their patients considering travel to perform Hajj or Umrah to ensure that those aged one year or older have received a MenACWY conjugate vaccine within the last 5 years administered at least 10 days prior to arrival in KSA. Healthcare providers should also maintain increased suspicion for meningococcal disease in anyone presenting with symptoms of meningococcal disease after recent travel to KSA for Hajj or Umrah pilgrimage. U.S. health departments and healthcare providers should preferentially consider using rifampin, ceftriaxone, or azithromycin instead of ciprofloxacin for chemoprophylaxis of close contacts of meningococcal disease cases associated with travel to KSA,” CDC said. While the advisory is targeted mainly for people in the United States, the experience of the COVID19 pandemic means that global attention will now be on this advisory. 

Meningococcal disease outbreaks have occurred previously in conjunction with mass gatherings including the Hajj pilgrimage. The most recent global outbreak of meningococcal disease associated with travel to KSA for Hajj was in 2000–2001

Race, age can confound artificial intelligence while analysing digital mammograms

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Race, age can confound artificial intelligence while analysing digital mammograms

Researchers called for using more demographically diverse data for research and testing purposes

 

An AI algorithm that is approved by the Food and Drug Administration can get confounded by the age and race of patients while analysing digital mammograms, a study has found. 

“Patient characteristics influenced the performance of a commercially available artificial intelligence algorithm analyzing true-negative screening digital breast tomosynthesis studies,” researchers reported in the journal Radiology. This calls for using more demographically diverse data sets for testing and training, they wrote. 

They found that false-positive risk scores were more likely in Black patients (OR = 1.5) and patients with extremely dense breasts compared with White patients and patients with fatty density breasts, respectively. The influence of patient characteristics on algorithm performance necessitates more demographically diverse data sets for testing and training and greater transparency.

“AI has become a resource for radiologists to improve their efficiency and accuracy in reading screening mammograms while mitigating reader burnout. However, the impact of patient characteristics on AI performance has not been well studied,” said Derek L. Nguyen, M.D., assistant professor at Duke University in Durham, North Carolina. 

In the retrospective study, researchers identified patients with negative (no evidence of cancer) digital breast tomosynthesis screening examinations performed at Duke University Medical Center between 2016 and 2019. All patients were followed for a two-year period after the screening mammograms, and no patients were diagnosed with a breast malignancy.

The researchers randomly selected a subset of this group consisting of 4,855 patients (median age 54 years) broadly distributed across four ethnic/racial groups. The subset included 1,316 (27%) white, 1,261 (26%) Black, 1,351 (28%) Asian, and 927 (19%) Hispanic patients.

 

Report adverse events in time: CDSCO reminds medical devices companies of 2015 programme

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Report adverse events in time: CDSCO reminds medical devices companies of 2015 programme

This is a requirement under the Materiovigilance Programme of India which was launched in 2015 to monitor quality and safety of medical devices in India

 

The Central Drugs and Standards Control Organisation (CDSCO) has reminded medical devices manufacturers that they are mandated to self report adverse events related to these devices.

 

Reminding the companies of their obligation under the Materiovigilance Programme of India which was launched in 2015 to monitor quality and safety of medical devices in India, the CDSCO has said that the appropriate platform should be used for this reporting. “As the MVPI is an important programme for the reporting of adverse events, coordinated analysis etc related to the medical devices, including in vitro diagnostic devices, therefore it is suggested that all the licence holder should also use the MVPI platform for the reporting of any adverse events/serious adverse events associated with the device to enhance the procedure for identifying risk associated with medical devices,” reads the circular.

The circular, according to sources in the organisation, is aimed at bolstering the post marketing surveillance of medical devices.The nodal agency for the implementation of the MVPI is the Indian Pharmacopoeia Commission. 

“The Materiovigilance Programme of India, launched by the Ministry of health and family welfare, Government of India with the objective to improve Indian patient, safety by monitoring, recording, and analysing the root cause of adverse events or risks associated with the use of medical devices, including individual diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies for appropriate action with the sole intention of improving patient safety…. Apart from healthcare professionals/general public/users/patients, the medical devices industries are one of the major stakeholders of MVPI, their participation needs to be encouraged to make significant impact in the outcome,” the circular adds.

 

Moms living with HIV can breastfeed; US experts reverse 40-yr-old advice, long after India did

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Moms living with HIV can breastfeed; US experts reverse 40-yr-old advice, long after India did

American Academy of Paediatrics has said that provided the mother is on anti retroviral treatment, she can breastfeed. India already allows breastfeeding by HIV+ moms

What India thinks today, USA thinks tomorrow!

India’s official policy on breastfeeding by HIV positive mothers with adequate precautions looks all set now to be adopted by the United States of America. Almost from the time that HIV has been known to man, breastfeeding by HIV positive mothers has been a complete “no no” in the United States for risk of transmission of infection. However the American Academy of Paediatrics (AAP) has now reversed that advice for parents who are extremely keen to breastfeed, are on anti retroviral treatment (ART) and have been properly counselled about the risks and necessary precautions.

In a new clinical report published in the journal Pediatrics, AAP has now said: “Breastfeeding should be supported for people with HIV who strongly desire to breastfeed after comprehensive counseling if all of the following criteria are met – 

ART was initiated early in or before pregnancy, there is evidence of sustained viral suppression in the parent (HIV viral load <50 copies per mL), the parent demonstrates a commitment to consistently taking their own ART and to giving infant ARV prophylaxis and the parent has continuous ART access.” However even in such a situation the parent needs to be told that risks are reduced and not eliminated with ART.

Centers for Disease Control and Prevention (CDC) had recommended against breastfeeding for people with HIV in the United States beginning in 1985. India however has an official policy of allowing all others to breastfeed irrespective of their HIV status provided both mother and baby are on appropriate retroviral medication. This is in line with the recommendations of the World Health Organisation. It is estimated that over 40% of vertical transmission (mother to child) of HIV occurs during breastfeeding in India.

 

Remove acknowledgement from Covaxin study, ICMR writes to BHU

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Remove acknowledgement from Covaxin study, ICMR writes to BHU

The study published in the journal Drug Safety had said that a third of Covaxin recipients had suffered adverse events of special interest

Indian Council of Medical Research has written to the the Banaras Hindu University asking for the acknowledgement to the apex research body be removed in its publication of a the university’s recent study which reported that a third of Covaxin recipients suffered adverse reactions.

“The Indian Council of Medical Research (ICMR) has been incorrectly and misieadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, the authors have acknowledged ICMR for research support without any prior approval.  ICMR cannot be associated with this poorly designed study which purports to present a “safety analysis” of Covaxin…” wrote ICMR director general Dr Rajiv Bahl in a letter dated May 18, 2024. The study was published in the journal Drug Safety.

In his letter, Dr Bahl identified some “critical flaws” in the study that makes the council loathe to be associated with it. He wrote that since the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups the adverse events could not be attributed to COVID-19 vaccination. Neither does the study provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. The baseline information of study participants is missing.

He added: “The study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)’ as defined in the reference provided in the paper for AEST. The method of data collection has a high risk of bias. Study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination.”

Most baby deaths in India occur in the first few days of life and again from the 29th day

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Most baby deaths in India occur in the first few days of life and again from the 29th day

Study that analysed data from the National Family Health Survey finds that most baby deaths happen in the early neonatal and post neonatal periods 

India needs to prioritize policies that focus on reducing child deaths soon after birth and then during the post neonatal period – that is after 28 days of birth. An analysis that looked at data from the National Family Health Survey 5 to identify the points at which baby deaths occurred the most found that early neonatal and post neonatal periods were when newborns were the most vulnerable. The findings were published in JAMA Network Open.

The study categorised child deaths into early-neonatal mortality rate (ENMR) (the number of deaths occurring in the first 7 completed days after the child is born), late-neonatal mortality rate (LNMR) (the number of deaths occurring on days 8 to 28 completed days after the child is born per 1000 live births, postneonatal mortality rate (PNMR) (the number of deaths occurring on days 29 to 11 completed months), and childhood mortality rate (CMR) (the number of deaths occurring in months 12 to 59 completed months who are at least aged 1 year). “The share of early-neonatal deaths to total under-5 deaths increased from 29.9% in 1993 to 48.3% in 2021, while the share of late-neonatal deaths decreased from 12.6% in 1993 to 9.7% in 2021, postneonatal deaths from 27.7% in 1993 to 25.6% in 2021, and child deaths from 29.8% in 1993 to 16.4% in 2021. Except for Kerala, Goa, and Nagaland, the remaining states and UTs with available data for both time periods experienced an increase in the share of early-neonatal deaths,” the researchers noted. Early neonatal deaths are higher because of factors like low birth weight and congenital disorders but the post neonatal phase is significant because at 42 days, the community health workers stop doing routine visits to the house of a newborn baby and the care passes on completely to the family without any supervision. Weekly ASHA visits stop at 28 days.

In India of every 1000 children born, 42 die before they reach their fifth birthdays, with the country accounting for 14% of the global burden of under-5 mortality. The Sustainable Development Goals (SDGs) of the United Nations include reducing mortality in the first 5 years to 25 deaths per 1000 live births and the first 28 days to 12 deaths per 1000 live births by 2030. Extrapolating from their analysis, the researchers wrote that going by this rate of change, India may not be able to meet the SDG targets of reducing early neonatal and post neonatal mortality.

 

Climate change can affect people living with neurological, psychiatric conditions: study

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Climate change can affect people living with neurological, psychiatric conditions: study

Changing weather conditions have caused a gradual rise in the surface temperature of the earth. 2023 was the hottest year in recorded history.

Nervous system conditions such as stroke, neurological infections and some mental health conditions can be aggravated by climate change, researchers have reported in The Lancet Neurology. They have called for robust studies for the protection of people living with these conditions.

Neurological disorders are the leading causes of disability-adjusted life-years (DALYs) – which are a measure of disease burden that takes into account the loss of productive years because of death or disability –  are the second leading cause of death globally. “Neurological diseases, and their treatments, can undermine all aspects of thermoregulation: for example, they can compromise adaptation to long-term rising temperatures and acute temperature elevations (eg, in heatwaves). Conversely, disease pathophysiology can itself be aggravated by normal thermoregulatory responses. For most diseases, the underlying mechanisms have not yet been well studied, but there are plausible links between climate change-related drivers (eg, higher temperatures) and consequent generation or disruption of pathophysiology, based on current understanding of how heat affects the human body,” the researchers wrote.

Climate change has not only caused erratic weather conditions – more frequent cyclones in some parts and unprecedented rainfall (such as the showers in the United Arab Emirates recently) in others – but it has also caused a gradual rise in the surface temperature of the earth. 2023 was the hottest year in recorded history. That psychiatric illnesses have a seasonal variation in presentation have been long known and with the character of seasons now changing the effect is inevitable.

Among the other diseases that the researchers have identified and the changes in which they have quantified are Alzheimer’s Disease and other dementias, migraine and tension type headaches, encephalitis, meningitis and epilepsy. “Approximately 60 million people have epilepsy. Most epilepsies share features likely to be aggravated by climate change, such as a sensitivity to sleep deprivation as a precipitant for seizures as sleep is, and will be, compromised by climate change, especially heatwaves,” they wrote. 

While listing limitations of the study, the researchers wrote about the paucity of data. One particularly compelling example they used was that while the vulnerability of children to climate change is well established there is lack of data on the effect of climate change on pediatric neurological and psychiatric illnesses. 

 

Looking to lose weight fast? Watch out, more than 0.5 Kg per week is not healthy, says ICMR

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Looking to lose weight fast? Watch out, more than 0.5 Kg per week is not healthy, says ICMR

Avoid anti-obesity drugs, rapid weight loss is the apex health body’s warning in a country besieged by obesity

Crash diets and rapid weight loss may lead to problems stemming from loss of crucial minerals in the weight loss diet or a diet that is too calorie poor to meet basic physical requirements. This is what the Indian Council of Medical Research says in its recently released dietary guidelines for Indians. It has also given  thumbs down to weight loss drugs that have just started becoming popular in the market.

“Regular physical activity and yoga are crucial to maintain good health and weight. Weight reduction should be gradual. Weight reduction diets should not be less than 1000 Kcal/day and should provide all nutrients. A reduction of half a kilogram body weight per week is considered to be safe. Approaches of rapid weight loss and use of anti-obesity drugs should be avoided,” the guidelines read. 

India has a very serious obesity problem. A The Lancet Study earlier this year found that 9.8% women and 5.4% men are battling obesity. In absolute numbers that is 44 million women and 26 million men aged above 20 years. These numbers have gone up significantly since 1990. For Asians a BMI of 27.5 Kg/metres square is considered obese – this is lower than international norms as Asians have a higher percentage of body fat. Over 12% urban and 5% rural adults are estimates to be obese. ICMR also estimates that over 31% urban and 16% rural adults are overweight that is they have a BMI of 23 to 27.5 Kg/m square.

Interestingly in a document where the dietary recommendations focus largely on vegetarian food groups such as leafy vegetables, fruits, legumes and cereals, ICMR has highlighted the importance proteins in an energy deficient weight loss diet. ‘Consuming higher amounts of protein (15% energy from protein) may be important during typical energy- deficient weight loss diets (i.e., 500–750 Kcal/day deficit) to preserves muscle mass. Nevertheless, the protective effect of higher-protein diets on muscle mass is compromised if the energy deficit is more than 40% of daily energy needs, and the dietary proteins are oxidized for energy production. Hence, it is advisable not to go beyond 40% energy deficit of daily energy needs to support muscle mass maintenance and protein balance,” read the guidelines.

 

FSSAI sounds mango season warning for traders; no calcium carbide

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FSSAI sounds mango season warning for traders; no calcium carbide

Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas which contains harmful traces of arsenic and phosphorus

It is mango season but it is not sweetness everywhere. The Food Safety and Standards Authority of India (FSSAI) has alerted traders’/fruits handlers/Food Business Operators (FBOs) operating ripening chambers to strictly ensure compliance with the prohibition on calcium carbide for artificial ripening of fruits. 

FSSAI has also advised Food Safety Departments of States /UTs to remain vigilant and take serious action and deal stringently against person(s) indulging in such unlawful practices as per the provisions of FSS Act, 2006.

Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas which contains harmful traces of arsenic and phosphorus. These substances, also known as ‘Masala’, can cause serious health issues such as dizziness, frequent thirst, irritation, weakness, difficulty in swallowing, vomiting and skin ulcers, etc. Additionally, acetylene gas is equally hazardous to those handling it. There are chances that calcium carbide may come in direct contact with fruits during application and leave residues of arsenic and phosphorus on fruits.

Due to these dangers, the use of calcium carbide for ripening fruits has been banned under Regulation 2.3.5 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. This regulation explicitly states, “No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, fruits which have been artificially ripened by use of acetylene gas, commonly known as carbide gas.”

Considering the issue of rampant use of banned calcium carbide, FSSAI has permitted the use of ethylene gas as a safer alternative for fruit ripening in India. Ethylene gas can be used at concentrations up to 100 ppm (100 μl/L), depending upon the crop, variety and maturity. Ethylene, a naturally occurring hormone in fruits, regulates the ripening process by initiating and controlling a series of chemical and biochemical activities. The treatment of unripe fruits with ethylene gas triggers the natural ripening process until the fruit itself starts producing ethylene in substantial quantities.

Further, the Central Insecticides Board and Registration Committee (CIB & RC) has approved Ethephon 39% SL for the uniform ripening of mangoes and other fruits.

FSSAI has published a comprehensive guidance document for food and business operators to follow the procedure for artificial ripening of fruits. 

 

45% prescriptions from tertiary care hospitals violate guidelines, 10% very serious

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45% prescriptions from tertiary care hospitals violate guidelines, 10% very serious

Study by the Indian Council of Medical Research flags the need for continuous training of doctors to prevent prescription violations

Inappropriate prescription of medicines remains a serious problem in India with just about half the doctors even in major hospitals adhering to standard treatment guidelines. A study by the Indian Council of Medical Research has found that the overall prevalence of deviations was 45 per cent of which 9.8% were what the researchers called “unacceptable deviations.”

The observational study was conducted in the outpatient departments of tertiary care hospitals in India wherein the 13 Indian Council of Medical Research Rational Use of Medicines Centres are located. “Against all the prescriptions assessed, about one tenth of them (475/4838; 9.8%) had unacceptable deviations. However, in 2667/4838 (55.1%) prescriptions, the clinicians had adhered to the treatment guidelines. Two thousand one hundred and seventy-one prescriptions had deviations, of which 475 (21.9%) had unacceptable deviations with pantoprazole (n=54), rabeprazole+domperidone (n=35) and oral enzyme preparations (n=24) as the most frequently prescribed drugs and upper respiratory tract infection (URTI) and hypertension as most common diseases with unacceptable deviations,” the researchers reported in the Indian Journal of Medical Research. Pantoprazole, rabiprazole are drugs known as proton pump inhibitors that take care of digestive problems while domperidone is an anti nausea medication.

Standard treatment guidelines have been in place for some time now but the study once again proves that Indian doctors even in some of the best medical centres choose to ignore those. Prescription audits that should be undertaken by hospitals on a regular basis are followed only in exception. The potential consequences of these deviations could be increased cost to the patient (301, 63%) and/or a probability of increase in the number of adverse drug reactions (254, 53%), drug interactions (81, 17%), anti microbial resistance (72, 15%) or even treatment failure (77, 16%), the study noted.

The community medicine OPD, followed by ENT and paediatrics had the most deviations. It is possible that the deviations in the community medicine OPDs were more in number as such OPDs are run by junior doctors.

“We recommend that the national and local treatment guidelines should be updated on a regular basis based on evidence, disseminated to the clinicians and prescribing according to these guidelines must be mandated by responsible local authorities. Moreover, training modules with case studies based on real-life scenarios that focus on rational prescribing and adherence to treatment guidelines need to be designed on an urgent basis for all prescribers, especially junior doctors,” the researchersrecommended. 

 

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