Germany Suspends Anti-malaria Drug Study for Covid-19

Coronavirus COVID-19: WHO expects anti-malarial drug hydroxychloroquine safety findings by mid-June

None of these data are publicly available.

In a letter to Swaminathan, three scientists-Dr Anurag Agarwal, director, CSIR-Institute of Genomics and Integrative Biology, Rajeeva Karandikar, Chennai Mathematical Institute, and CSIR chief Dr Shekhar Mande-have questioned the methodology of the Lancet study based on which the WHO trial has been paused, and called the global health body's action "knee-jerk".

The review will consider data collected so far in the Solidarity Trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug, he said.

ICMR said there were no major side-effects of HCQ found in studies in India and its use can be continued in preventive treatment for COVID-19 under strict medical supervision, the Indian Council of Medical Research (ICMR).

Lancet, published 22 May 2020.

According to the Health Ministry, recommendations to use HCQ have come from various foreign studies confirming its effectiveness, and it has been included in several national and worldwide clinical guidelines, including in Russian Federation.

"The article represents an observational study". Patients who received none of the treatments formed a control group. It studied records from 96,032 patients hospitalised between December 20, 2019, and April 14, 2020, and sought to investigate whether COVID-19 positive patients on HCQ alone, HCQ combined with an antibiotic, choloroquine (CQ, an older version of HCQ), and CQ with an antibiotic, benefited over those who were on other treatments.

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 China's Wuhan and the World Health Organization published the first disease outbreak news on the new virus only on January 5, 2020. The first case was recorded in the U.S. on January 20.

"Data from Africa indicate that almost 25% of all COVID-19 cases and 40% of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording, and patient monitoring able to detect and record 'nonsustained [at least 6 secs] or sustained ventricular tachycardia or ventricular fibrillation.' Both the numbers of cases and deaths, and the detailed data collection, seem unlikely". "They have not released their code or data", the letter stated.

"Even if the data were correctly extracted, severe flaws remain".

The "main error", they say-which is true for all observational studies-is the baseline difference between the groups and the statistical methods to adjust for these differences. In response, New Zealand's drug agency Pharmac even had to put new restrictions on the use of hydroxychloroquine to prevent Kiwis following the president's advice.

Surgisphere in a statement said that its data use agreements do not allow it to make some data public.

The observational research, led by Mandeep Mehra of the Brigham and Women's Hospital in the USA, looked at records from 96,000 patients in hundreds of hospitals between December and April and compared those who received treatment with a control group.

"Overall, this suggests that receiving the treatment was based on the severity of symptoms".

Germany is looking at The Lancet study and the WHO's decision but has not made any decision about new guidance on hydroxychloroquine, a spokeswoman for its drugs regulator said.



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