
By Suchitra Mukherjee
New Delhi [India], May 30 (ANI): Council of Scientific and Industrial Research (CSIRĀ ) Director-General Shekhar Mande, Institute of Genomics and Integrative Biology (IGIBĀ ) Delhi Director Anurag Agarwal and Chennai Mathematical Institute (CMI) Chennai Director Rajeev Karandikar have written to the World Health OrganisationĀ (WHO) and asked the global health body to resume trial of hydroxychloroquine (HCQ) for the treatment of COVID-19Ā patients as early as possible, asserting that the Lancetās study is not correct.
In an email to LancetĀ paper editor Richard Charles Horton as well as WHO, Mande stated the study published in LancetĀ on HCQĀ and chloroquine and its effect on COVID-19Ā is an observational study with statical parameters and analysis, which is not sufficiently good.
It also stated that the decision of WHOĀ to temporarily suspend quality HCQĀ trials based on findings of the LancetĀ study appears to be a āknee-jerk reactionā.
Mande said that the study design and statistical interference are not right and therefore, it does not deserve any attention of the readers. āIn our considered opinion, the decision of WHOĀ is questionable and the statistical analysis is not correct.
LancetĀ paper is not sufficiently rigorous, rather it is faulty and therefore, the decision of the WHOĀ to temporarily halt the study is not correct. We have written an email to the WHOĀ that the decision is not right and the HCQĀ clinical trial must resume as early as possible,ā Mande said.
The email refers to the article in LancetĀ āHydroxychloroquineĀ or chloroquine with or without a macrolide for treatment of COVID-19Ā : a multinational registry analysisā, which present an analysis of the hospital registry data on the effect of HCQĀ on COVID-19Ā patients.
According to the letter, the article published in LancetĀ appears to give a sense of legitimacy to the findings and consequently has led to the suspension of HCQĀ trial by the WHO. āHowever, the study has several limitations as the authors have themselves acknowledged in the article. Thus, using this study to halt the use of HCQĀ or chloroquine in the ongoing controlled trial seems questionable,ā it said.
āThe article represents an observational study. Unlike randomised blinded trials where subjects are chosen randomly to receive treatment, to minimise differences between treatment groups in this study, there has been no such prior design.
The methodology of the paper mentions that all patients who were hospitalised between December 20, 2019, and April 14, 2020, with PCR confirmed COVID-19Ā infection were analysed,ā read the letter.
The research bodies said that first reported symptoms of the diseases was a cluster of pneumonia cases which were recorded on December 31, 2019, in Chinaās Wuhan and the WHOĀ published the first disease outbreak news on the new virus only on January 5, 2020.
āMoreover, it was only on January 20, 2020, that the first case was recorded in the US. Thus, scanning the records of hospitalisation from December 20, 2019, appears to be unjustified.
While it is not expected to make any difference since PCR confirmation would not be there for non-COVID cases, it is worth noting that the number of patients and the number of deaths in this study are inconsistent with public health records of the same, often exceeding them despite surveying only a subset of healthcare organisations,ā read the letter.
They said that this raises concern for errors in data extraction from electronic records. āEven if the data were correctly extracted, severe flaws remain. The main problematic area here, as in all observational studies, is the baseline differences between groups and application of statistical methods to adjust for them,ā the letter stated.
āClearly, in this Electronic Health Record (EHR) data-driven study, without any inputs of local treatment protocols, we do not know whether the patients, who were administered chloroquine/hydroxychloroquine were chosen based on ā the severity of symptoms, the number of symptoms reported/observed or location-specific: some hospitals gave it to all (or most) and some gave to few.
If so, then the conclusions have no value, because the confounding factors that this choice introduces cannot be statistically corrected using available data,ā it said. The research bodies said that on various parameters, the patients who were given chloroquine/ hydroxychloroquine seem to be doing far worse.
āTable 2 shows that the control group has the lowest baseline severity markers, BMI, proportion of males, coronary artery disease, congestive heart failure, diabetes and hypertension amongst all groups.
These represent all the major known risks and while individual differences are small and may lack statistical significance, it appears likely that physicians were selecting for sicker patients while assigning treatment with HCQĀ /CQ,ā the letter said.
āThis is not unexpected here and highlights the well-known problem of statistical comparisons of unbalanced unrandomised groups in observational studies.
Conventional statistics test the null hypothesis, which is automatically rejected if the groups are likely to be dissimilar. Little value is then added by confidence intervals and p-values in determining whether differences are causally related to the intervention label of the group,ā it said.
āOverall, this suggests that receiving the treatment was based on the severity of symptoms. While this does support the lack of high effectiveness of HCQĀ /CQ therapy, the decision of WHOĀ to temporarily suspend quality HCQĀ trials based on findings of this study appears to be a knee jerk reaction,ā it further said. (ANI)
France officially bans hydroxychloroquine as treatment against COVID-19
Paris [France], May 28 (Sputnik/ANI): FranceĀ on Wednesday (local time) officially banned hydroxychloroquine as a treatment for COVID-19Ā after a series of medical studies revealed that the malaria drug could be harmful.
The decision came a day after French health organisations, namely, the HCSP health advisory and ANSM drugs agency, advised against using hydroxychloroquine for COVID-19Ā treatment, considering its negative side effects.
Moreover, the agency announced that like the World Health Organisation (WHO) did on Monday, it would also pause clinical trials with the drug amid safety measures. āā¦This drug (hydroxychloroquine) should not be prescribed to patients with COVID-19,ā a statement published by the French Health MinistryĀ said.
The French authorities allowed the use of hydroxychloroquine, also prescribed against malaria, in hospitals for COVID-19Ā patients at the end of March, as there has been no vaccine or any other approved treatment against the disease.
However, according to the study published in the British medical journal, The Lancet, the drug increases the risk of death among the ill and worsens other symptoms, as other studies have concluded. Notably, the drug has its supporters.
Particularly, US President Donald TrumpĀ and Brazilian President Jair Bolsonaro have promoted the use of hydroxychloroquine as a treatment for coronavirus. As of Wednesday, FranceĀ has reported 182,847 COVID-19Ā cases, the worldās seventh-highest total, with 28,533 related fatalities. (Sputnik/ANI)Ā