(In the weekly Health Matters newsletter, Ramya Kannan writes about getting to good health, and staying there. You can subscribe here to get the newsletter in your inbox.)
Famous last words. Or, first. We wondered if the sordid vaccine issue had been set to rest, last week, but that is not to be. In the endless, sometimes cyclical news cycle, things get pushed up to the top, inevitably, in similar avatars, or different, seeking resolution or conclusion. Often there is no conclusion, just endless episodes and series that keep the story going long, long after the show started. While last week, the health community was all aflutter with the Covishield side effects controversy, this week, it has been about Covaxin, a study and a consequent flip flop.
Bindu Shajan Perapaddan reported the study done by the Benares Hindu University researchers and published in Springer Nature recently. It concluded that adolescent girls and those with comorbidities are at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19. Further, it said that nearly a third of the participants of an observational study on the vaccine reported adverse events of special interest (AESI). Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with comorbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with comorbidities had more than 2 times higher odds of AESIs and persistent AESIs,” the paper said.
But that was not all. In a counter to the study, the Indian Council of Medical Research, that was acknowledged in the original paper, distanced itself, in a couple of days. ICMR, it may be recalled was involved with Bharat Biotech in the development of the vaccine. In its letter to the researchers, the ICMR said the body has not provided any financial or technical support for the research. ICMR director general Rajiv Bahl called the paper “poorly designed” and said it “incorrectly and misleadingly” acknowledges financial or technical support from the ICMR. “ICMR cannot be associated with this poorly designed study,” the director general’s letter says, and calls for an immediate retraction of the hat tip to ICMR from the article, and publish an Erratum. “We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek legal and administrative action against you,’’ it notes.
What were the flaws in the study? According to the ICMR, it does not have a control group of unvaccinated individuals to prove that the side effects are indeed associated with vaccination. Also, it does not mention how frequently these adverse events were reported by the sample population to establish that they were associated with vaccination, the study tool was not consistent with the definition of “adverse events of special interest” that is globally accepted and lastly the responses of the participants were recorded one year after immunisation without verification of any clinical records or physician examination, increasing the chances of biased reporting.
BHU issued a statement later saying: “The Institute of Medical Sciences is looking into the matter. The individuals have communicated their responses to the ICMR. Additionally, the Institute of Medical Sciences is also working on further strengthening and improving its research ecosystem,” the BHU said.
Let’s note the bizarre circumstances of this publication and the counter, while we acknowledge that much more needs to be done in the country to regulate scientific research and hold it up to the highest accountable standards. The ICMR’s sudden discovery of the use of its research, data or even merely name belatedly is also something that rankles. We’ll stay on this story, you stay with us.
Relatedly, the Drugs Controller General of India called for strict reporting of side effects related to medical devices. The drug regulator said that the post-market surveillance (PMS) of medical devices is one of the important aspects to ensure the safety and performance of the medical devices.“PMS supports identifying and addressing any potential risk or adverse event associated with the medical device. Timely reporting of the adverse events allows for the identification of unidentifiable risks, analysing frequency of already identified risks and enabling the manufacturers and regulatory authorities to take appropriate measures to mitigate risks and safeguard public health,” the DCGI said.
Bringing in the gender lens onto health care, and there is much to celebrate. Some hope comes from a study which showed that the new breast cancer genes found in women of African ancestry may improve risk assessment. 12 breast cancer genes identified in women of African ancestry in a large study published on Monday may one day help better predict their risk for the disease and highlights potential risk differences from women of European descent. The new findings are drawn from more than 40,000 women of African ancestry in the United States, Africa and Barbados, including 18,034 with breast cancer. Why did we take so long to arrive at this? Simply because apparently, studies to identify genetic mutations linked with breast cancer have previously mainly focused on women of European ancestry. Yes, it took several centuries for some historic wrongs, and perhaps idiocy to be corrected, but at least we are learning now.
Another study showed that the HPV vaccine prevents cervical cancer cases in deprived groups in the U.K. After carrying out the longest follow-up on the effectiveness of the HPV vaccine, researchers at the Queen Mary University of London concluded the HPV vaccination programme in England is helping to close some inequalities in cervical cancer. The results were published in the journal BMJ. Due to a typically higher incidence of cervical cancer in more deprived groups, researchers found that more cases were prevented in the most deprived group (around 190), compared to the least deprived group (around 60) in a study that included approximately 6,50,000 people offered vaccination aged 12-18 years in each of the five deprivation groups. The study reflected the huge success of the school-based vaccination programme, showing that well-executed public health interventions can help to reduce health inequalities.
There’s more good news, reports Purnima Sah. Anaemia among pregnant and lactating women is down from 52% to 38% in Mumbai slums, according to a survey. The survey was conducted on mothers living in vulnerable settlements in Mumbai’s Mankhurd, Govandi and Dharavi which included nutrition counselling and identification and referral of child malnutrition in collaboration with ICDS and health system staff. The report highlights significant improvements in child-feeding practices among mothers, including adherence to exclusive breastfeeding for the first six months, appropriate initiation of complementary feeding, and diet quality such as meeting minimum meal frequency and acceptable diet requirements for young children.
And we have run out of the good news. Something to sober us up now: Maitri Porecha reports the results of the study that women with no sexual autonomy are twice as likely to get STIs. Women who had controlling husbands and had experienced intimate partner violence in their married life are more at risk of developing sexually transmitted infection (STI) or reproductive tract infection (RTI) than women who do not report facing control or intimate partner violence (IPV) in their marriage, it reveals. The study analyses data obtained from a sample size of 73,895 women in National Family Health Survey-5 (2019-2021). Lessons in this for policy makers, surely?
Once again, the Supreme Court rejected a plea for termination of an over 27-week pregnancy, using the same argument it has used before - the foetus has a fundamental right to live.
Continuing on a story that made headlines earlier, here’s an update. What we put into our mouths clearly is not adequately monitored. After Hong Kong last month suspended sales of three spice blends of MDH and one of Everest, saying they contained high levels of a cancer-causing pesticide, ethylene oxide, Singapore ordered a recall of the Everest spice mix. Now, New Zealand is reportedly looking into Indian spice brands MDH and Everest over contamination complaints. Nepal bans the sale of Indian spice-mix products over quality concerns. FSSAI has also called for quality checks on the brands’ spice packets.
Meanwhile, the summer alert from FSSAI has gone out again, asking fruit traders and food businesses not to use the banned product ‘calcium carbide’ for fruit ripening. The use of calcium carbide for artificial ripening of fruits, particularly during the mango season, has been prohibited. Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas, contains harmful traces of arsenic and phosphorus, and can cause serious health issues such as dizziness, frequent thirst, irritation, weakness, difficulty in swallowing, vomiting and skin ulcers, etc, FSSAI said.
Meanwhile, in an important development, the WHO updated its Bacterial Pathogens Priority List as critical priority pathogens continue to present a major global threat. This includes gram-negative bacteria resistant to last resort antibiotics, and Mycobacterium tuberculosis resistant to the antibiotic Rifampicin. The list features 15 families of antibiotic-resistant bacteria grouped into critical, high and medium categories for prioritisation. Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, making people sicker and increasing the risk of disease spread, illness and death. “AMR is driven in large part by the misuse and overuse of antimicrobials,’’ the document says.
The past week also presented an opportunity to observe World Hypertension Day. Here, Chandrakant Lahariya and Balram Bhargava offer some health advice to take, notably, with no pinch of salt. In its 2023 report: “Global report on hypertension: the race against a silent killer”, the WHO said hypertension was considered a silent killer as people often are not aware about high blood pressure till they develop complications. High blood pressure is the single most important risk factor for early deaths, leading to an estimated 10.8 million preventable deaths every year, globally. High blood pressure causes more deaths than other leading risk factors. The authors list out a number of things that governments could do to control the hypertension epidemic, but also stress that restricting the intake of dietary salt is a key intervention that every one can immediately implement.
In our tailpiece of the week, meet ‘XoRehab’. It is an Internet of Things (IoT) enabled wheelchair device to help in the rehabilitation of stroke patients post-surgery, Jahnavi T. R. reports. IIIT-B researchers have developed an IoT-enabled wheelchair device for the rehabilitation of stroke patients. Madhav Rao of IIIT-B, explained: “One of the neurosurgeons at Nimhans suggested that we develop a portable device (for rehabilitation) that patients can take home for lease from the hospital and bring back, once they are better. Hence, we started developing this device.” The XoRehab is an exoskeleton for rehabilitation with nine Degrees of Freedom (DoF), which essentially means it allows joint movement in both the upper and lower limbs. “This is a home-based rehabilitation device, and it is not necessary to shift a person from one device to another between upper and lower limb rehabilitation. It involves the development of well-trained robots on electromechanical actuation,” the researchers said. More importantly, while physiotherapy is mostly mechanical and requires constant supervision from the caretaker to check if the patients are doing it the right way, the XoRehab eliminates the need for it due to its IoT-enabled system.
We take our explainers seriously, particularly on health issues, as we endeavour to break it down, and draw together different strings, for our readers. This week, here are a few current explainers you might want to check out.
Where does India stand in the field of computational drug development? Binay Panda provides some clarity: The use of AI in drug development.
R. Prasad explains if humans get H5N1 infection by consuming raw milk.
For all you wanted to know about the West Nile Virus, do read C. Maya’s story here: Kerala sounds warning on West Nile Virus before monsoon; neighbouring states on guard.
Zubeda Hamid’s In Focus podcast examines what’s behind the furore over the AstraZeneca vaccine.
From the Health page
If you have a few more moments, do click on the links below:
Somdatta Karak reports: Balancing two forms of SNCA protein could help manage Parkinson’s.
Tejah Balantrapu and Soumyava Basu write on the challenge of extra-pulmonary TB.
S. Vijay Kumar says: Centre sets timeline for disposing living donor transplant applications.
Sayantan Datta reports the conclusions of a study that showed that general and central obesities are linked to higher risk of colorectal cancer.
Afshan Yasmeen reports on a NIMHANS study in nine States that reveals a significant prevalence of anxiety and suicidal thoughts among college students.
For many more health stories, head to our health page, and subscribe to the health newsletter, here.
