This was done after peer reviewed medical journal The Lancet said that HCQ can lead to increased mortality rates and came with risks of adverse effects like cardiac arrhythmia. On Wednesday, The Lancet red-flagged the study. It has issued a statement of concern now after more than 100 scientists across the world flagged discrepancies in its recent study.
"We are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information," the editors of the journal said.
On Thursday, WHO Director General Tedros Adhanom Ghebreyesus said in a tweet: “On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol. The Executive Group will communicate with the principal investigators in the trial about resuming the hydroxychloroquine
arm of the trial.”
It has a well established safety profile as rheumatoid arthritis
patients use the drug daily. "The drug is well tolerated and is very safe. Patients use it daily. This entire issue around HCQ raising mortality or causing cardiac disorders. The drug is also used as a third line therapy in diabetes. Diabetes patients have cardiac risks. Thus this entire controversy seemed to be very misleading," said a senior official of a drug firm.
Another industry source felt that there were vested interests at play to pull down or raise doubts about using a drug that is inexpensive. "If HCQ works in Covid-19, then that would hit the market of repurposed expensive drugs," he said wishing to remain unnamed.
The Lancet research that was published on May 22 was an observational study of 96,032 hospitalised Covid-19 patients from six continents that reported substantially increased deaths, and incidences of heartbeat rhythm changes associated with the use of the drugs HCQ and closely related chloroquine.
"If we don't have a double blind randomised controlled trial (RCT), where the neither the doctors nor the patients know what drug they are on, conclusions are always subject to bias, and The Lancet study was not and RCT," explained Ram Vishwakarma, Director of CSIR-Indian Institute of Integrative Medicine (CSIR-IIIM) in Jammu.
India's apex health research body - the Indian Council of Medical Research (ICMR) - however, was not affected by the global controversy. It carried out three studies and as result, it issued an advisory to expand the use of HCQ as a preventive therapy. ICMR advised a lower dose of HCQ for prophylatic use and also wrote to the WHO disagreeing with its advisory to suspend the use of HCQ in treating Covid19 patients.
In its advisory for Indian patients, ICMR said, "In clinical practice HCQ is commonly prescribed in a daily dose of 200mg to 400mg for treatment of diseases such as Rheumatoid Arthritis
and Systemic Lupus Erythematosus for prolonged treatment periods with good tolerance. With available evidence for its safety and beneficial effect as a prophylactic drug against SARS-COV-2 during the earlier recommended 8 weeks period, the experts further recommended for its use beyond 8 weeks on weekly dosage with strict monitoring of clinical and ECG parameters which would also ensure that the therapy is given under supervision."
Indians are to be given one heavy dose of HCQ (400mg ) twice on the first day of treatment, followed 400 mg once a week for three weeks (for asymptomatic household contacts) and for 7weeks for healthcare workers. Internationally, patients were being given 800 mg doses followed by 400 mg doses.
(With inputs from PTI)