ICMR Approves Chloroquine For COVID-19. Here's Why It's a Problem
Why would ICMR approve an anti malaria drug as a COVID-19 prophylactic when it is yet to be scientifically tested?
The National Task Force for COVID19 constituted by Indian Council of Medical Research has just recommended the use of anti malaria drug hydroxychloroquine as a prophylactic for high-risk populations such as those in close contact with confirmed cases.
Asymptomatic health care workers in close contact with cases of laboratory confirmed COVID-19
Asymptomatic close contacts (like household contacts) of positive COVID-19 cases
It should not be given to children under 15 years of age
While the ICMR advisory also clarifies that this new treatment should be used as an addition to the already existing public health and hygiene guidelines, here's why it is highly problematic.
The noise around chloroquine, and its derivative hydroxychloroquine has been building up for a few days based on a small French study and the US President Donald Trump himself. Hard-selling the drug in a press conference, he said, "We're going to be able to make that drug available almost immediately, and that's where the FDA has been so great. They've gone through the approval process, it's been approved."
Here's the problem. The US Food and Drug Administration has not approved the drug for use, it has approved the drug for trials.
During the same press briefing, US Food and Drug Administration director Dr Stephen Hahn clarified that the drugs will be used in a clinical trial.
"What’s also important is not to provide false hope. We may have the right drug, but it might not be in the appropriate dosage form right now, and it might do more harm than good.”Dr Stephen Hahn, Director, US FDA
Is ICMR Basing its Decision Based On a Tiny Study?
Is the drug promising? Yes. But should a drug not go through proper testing in a scientific setting before it is approved for use?
The source of this hope around chloroquine, and its derivative hydroxychloroquine is a small French study yet to be published in a medical journal. Researcher Didier Raoult from Aix-Marseille University in France released encouraging results of a preliminary trial involving a total of 36 COVID-19 patients. Most of these patients had mild to moderate symptoms. Between 1st to 15th March the researcher and his team treated 20 of these patients with 600 milligrams of hydroxychloroquine daily. An antibiotic called azithromycin was added to the treatments for specific symptoms. 16 patients were not given the drug.
The result? There was a significant reduction in viral load in the patients treated with hydrooxychloroquine. 70 percent of those given the drug showed up COVID-19 negative in six days.
Among the control group the number was just 12.5 percent. While the paper has yet to be published, the study considered too small to be significant, the results were released in the hope of starting larger, more scientific drug trials. The US FDA is now planning to do just that.
To be fair, there have been other studies that have linked the drug to coronavirus treatment. The medical journal Clinical Infectious Diseases reported on 9 March that a brand-name version of hydrooxychloroquine was effecting in killing coronavirus in laboratory experiments. Plaquenil is an already approved drug for malaria and arthritis. However, even this data was not considered enough by experts to draw out major conclusions.
Should ICMR be Recommending it as a Prophylactic?
Scientists have identified 69 drugs and experimental compounds that could be effective in treating the novel coronavirus and the COVID-19 disease and chloroquine is among them. USFDA has approved the use of the drug on 'compassionate grounds' in some cases. It is clinically a safe drug to use. But should the top medical body of the country be issuing it as a prophylactic based on small studies that have yet to be replicated?
Dr Naresh Trehan, India's leading cardiologist and founder of Medanta hospitals, in a video posted online said that Hydroxychloroquine works as an “immune modulator”. “Immune modulators help reduce the effect of a virus or white cells on our body by reducing immunity. When someone is infected by coronavirus, it might work, but if we use it prophylactically it might also end up making a person more vulnerable to infection.”
The Quint also reached out to Dr Suranjit Chatterjee from Apollo Hospitals who mentioned that there is no cure known for the virus yet and one must not fall for “WhatsApp medicine”.
“The study was conducted on a very small sample of patients and multiple other studies are being conducted. However, social distancing and personal hygiene are the only known precautions against coronavirus,” he added.
The New York Times quotes Nevan Krogen, a biologist at the University of California who led another study on the drug, as saying that chloroquine may have ‘toxic side effects because the drug appears to target many human cellular proteins.
“You need to be careful. “We need more data at every level”, he said.
But then on what basis is India's top research body allowing the use of the drug as prophylactic?
(Subscribe to FIT on Telegram)
Subscribe To Our Daily Newsletter Now.