Demand for controversial drug Hydroxychloroquine surges despite lack of clinical evidence to treat coronavirus

New Delhi: With US President Donald Trump describing hydroxychloroquine as a "game changer" in the fight against COVID-19 and several countries, including India, approving it for emergencies, pharmacies are reporting a surge in demand for the drug yet to be proven as a cure against the disease.

Though there have been no large-scale clinical trials of the drug's efficacy in treating coronavirus, chemists all over say they are facing a shortage of the medicine, not so long ago known mainly to those who had malaria or were prescribed it for arthritis pain.

Hydroxychloroquine entered the layperson's lexicon with Trump's tweet on March 21.  A few days later, several countries approved it for restricted use in coronavirus emergencies and for certain categories of people only.

And while the White House's own infectious disease expert Dr Anthony Fauci countered the claims, adding that the drug's effectiveness was only "anecdotal" and needed controlled clinical trials to prove its effectiveness, Trump's tweets had already had a ripple effect across the globe.

"The drug has been out of stock ever since Trump tweeted about it," a pharmacist from New Delhi's Kailash Colony told PTI on the condition of anonymity. He added that efforts are being made to restock the medicines.

Asked about the current availability of the drug in the country, a pharmacist in the city's Govindpuri area said the drug has been out of stock in his store for days. He also expressed concern that patients with joint aches and other bone related conditions are being deprived of the drug, prescribed to them by their doctors.

"We do not have a supply for more than a week and we have asked the distributors to resupply the medicine," added another chemist nearby.

According to Dr Rohini Handa, senior consultant rheumatologist at Apollo Hospital in New Delhi, arthritis patients have been finding it difficult to get hydroxychloroquine for the last 10 days.

"Ever since news came out in the media that it may help fight coronavirus infection, there has been indiscriminate buying by people. So it seems to have disappeared from the market," Handa told PTI.

"Everyday I am getting phones, and emails from my patients who are not able to get it. In rheumatology, this is an anchored drug for many conditions. And we are apprehensive that the non availability may lead to a flare-up of arthritis in these patients, he explained.

People need to realise that not every person in this country needs hydroxychloroquine, Handa said.

Two days after the US president's tweet, the Indian Council of Medical Research on March 23 recommended that the drug be reserved in India only for healthcare workers, and persons caring for COVID-19 patients in households.

The protocol was then approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations

"Hydroxychloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from the available evidence of benefit as treatment and supported by preclinical data," the DGCI's advisory said.

Estimating a surge in global demand for the drug, the Indian government banned the export of hydroxychloroquine with immediate effect to ensure sufficient availability of the medicine in the domestic market.

An exception of sales to other countries on humanitarian grounds was made on a case-to-case basis.

On March 28, Raman R Gangakhedkar, head of epidemiology and communicable diseases at ICMR, said a reduction in the viral load was observed in patients treated with hydroxychloroquine. He later added that the drug be given only to doctors and contacts of lab-confirmed COVID-19 cases.

While the demand for hydrochloroqine has seen a rapid uptick, the safety and effectiveness of the drug in treating COVID-19 still remains a concern.

Recent research, published in the preprint platform MedrXiv, said the anti-malarial drug could have a protective function against COVID-19, but cautioned that the number of people involved in the study was very few.

The study also said the drug's side potential effects in people must be taken seriously.

"Despite our small number of cases, the potential of HCQ in the treatment of COVID-19 has been partially confirmed. Considering that there is no better option at present, it is a promising practice to apply HCQ to COVID-19 under reasonable management," the scientists from Renmin Hospital of Wuhan University in China wrote in the study.

"Large-scale clinical and basic research is still needed to clarify its specific mechanism and to continuously optimize the treatment plan," they concluded.

The study, initially cited by Trump, also had a very small sample size of26 patients treated with hydroxychloroquine and 16 control patients.

Other studies have cautioned that the drug must be administered with care since its long-term use is reported to have side-effects, including impairment or loss of vision, gastrointestinal reactions, cramps, liver dysfunction, itching, and headaches.

Hydroxychloroquine and the antibiotic azithromycin, which are being considered by some for treating COVID-19, may increase the risk for dangerous abnormal heart rhythms, US cardiologists have warned.

The researchers from Oregon Health & Science University (OHSU) and Indiana University recommend that clinicians treating COVID-19 patients with the malaria-antibiotic drug combination should consider monitoring those patients for ventricular arrhythmia.

The condition leads to the lower heart chambers beating quickly and irregularly, and can lead to cardiac arrest, they said