India, US And An Unproven Drug Using To Treat COVID-19 Patients – OpEd
As the Government of India and its state governments are getting ready to treat Covid-19 patients by use Hydroxychloroquin (HCQ) the rise of death toll has shown a futility of HCQ.
Experts have already warned that if governments follow this only way it would not be possible to check the Coronavirus death cases. No country has specific effective medicine and method to fight against Covid-19 so far. But after US President Donald Trump’s request for treatment of Covid-19 in USA, India and Indian doctors’ confidences on Hydroxychloroquin have been grown. Hydroxychloroquine has been identified by the US Food and Drug Administration as a possible treatment for the COVID-19 and it is being tested on several thousands coronavirus patients in New York.
India, the largest producer of hydroxychloroquine, agreed to lift the ban on the export of the medicine to the US after Trump spoke to Prime Minister of India Narendra Modi on phone last week. Three Gujarat-based companies have shipped these tablets to the US.
President Trump has described Prime Minister Narendra Modi as “terrific” for allowing the export of the anti-malarial drug Hydroxychloroquine to the US, seen as a possible cure for COVID-19, saying India’s help in the extraordinary times “will not be forgotten”.
As a result of Trump’s collection, excitement about decades-old unproven anti-malarial drugs to treat the COVID-19 patients has touched off widespread interest in the medications, hoarding by some political leaders in power and doctors, new clinical trials on the fly and desperation among patients who take them to be cured.
As Covid-19 spreads in India and Trump’s interests on HCQ, Indian pharmaceutical companies are raising monthly production of anti-malarial drug Hydroxychloroquine (HCQ) four times to 40 metric tonnes (MT) by the end of this month and five to six times to over 70 metric tonnes (MT) by next month. The plan to step up production came after the Government of India indicated it will help countries in dire need of the drug to fight novel coronavirus. The country has a production capacity of 40 tonnes of Hydroxychloroquine (HCQ) every month, implying 20 crore tablets of 200 mg each. Leading manufacturers of HCQ like Intas Pharmaceuticals, McW Healthcare of Indore, Macleods Pharmaceuticals, Cipla and Lupin have been asked to accelerate the production of HCQ. API suppliers for the drug include Abbott India, Rusan Pharma, Mangalam Drugs, Unichem Remedies, Laurus Labs, Vijayasri Organics, etc. Peak capacity would produce 35 crore (350 million) tablets of 200 mg dosage every month.
India’s own requirement is unlikely to exceed 10 crore tablets for which the government has already placed an order with leading domestic manufacturers Zydus Cadila and Ipca Laboratories. Industry experts say 10 crore tablets are good enough to treat seven crore people, if required. In India, HCQ costs less than Rs 3 per tablet.
But most of Indians have not paid medical attention that it is a strong medication never adequately tested for efficacy or safety in COVID-19 patients. Many experts warn there isn’t enough evidence that the drugs work for the coronavirus, but at least a few say there’s little to lose in giving hydroxychloroquine to patients who are severely ill with coronavirus.
Ironically, HCQ is no more a primary anti-malarial drug. It is mostly used globally to treat some immunological diseases like Lupus and Rheumatoid Arthritis. Indian drug formulators export 80-85 per cent of the production to almost all parts of the world, as global pharma majors more or less stopped large scale production of this low cost molecule due to lack of demand. And since the drug is also used for auto-immune diseases like Rheumatoid Arthritis and Lupus, manufacturers have good production capacities that can also be ramped up.
The drugs, Hydroxychloroquine and Chloroquine, Coronavirus treatment to ease symptoms, or as a preventative drug to stop people being overcome with the infection. Trials are exploring use of the drugs on their own as well as in combination with others.
But clinicians have warned that Hydroxychloroquine can cause severe and even life-threatening side-effects, and have cautioned against using it for conditions for which it has not been tested. It is a proven treatment for malaria and for some autoimmune conditions.Studies on its efficacy as a COVID-19 preventative or treatment are mixed. Much of the focus on the drug came after a small French study, which has since been widely disputed and been found to have omitted data contain spurious results. A small study from China found no benefit to chloroquine being given to COVID-19 patients.
The medicine affects the heart’s rhythm and a doctor prescribing it would be alert to this, said Anurag Bhargava, Professor of Medicine at Mangalore’s Yenepoya Medical College, who has over two decades of work on infectious diseasesHCQ has been useing to treat malarial patients for decades but has been proved iin Covid-19 cases. It was tested previously in several viral illnesses but never found effective. According to Dr. Raymond L. Woosley,a professor of medicine at The University of Arizona, College of Medicine-Phoenix, there is no evidence whatsoever that HCQ can prevent COVID-19, and there is only anecdotal evidence that it improves the course of the disease. The reports that it can reduce the measurable levels of the virus in patients are seriously flawed, lack a valid control group and were released to the public with little, if any, scientific review. Proper clinical trials with HCQ are underway, but these will take months. In summary, doctors do not know if HCQ or any other drug now being tested is effective or will have any medical benefit.
In USA, doctors are also trained to use their medical skills to evaluate the patient’s overall condition as part of the risk/benefit equation for a drug and to take appropriate measures to mitigate any risks. They know that some patients are at greater risk of developing side effects than others. Unfortunately, the patients at greatest risk for most of HCQ’s serious side effects are the same as the very sickest COVID-19 patients, e.g. those on respirators with low blood oxygen levels and with disturbances in body chemistry, Dr Wooseley says.
Continuous ECG monitoring is one of the methods used to prevent potentially lethal cardiac effects of HCQ and chloroquine. In many ICUs, computerized decision support systems monitor the patient’s electronic chart and send advisories to physicians when a drug’s risk exceeds safe thresholds. However, these surveillance tools are not generally available outside of the hospital and could not protect those who might try to prevent COVID-19 by taking HCQ.
Pandemics and other public health tragedies alter the usual norms and requirements of medical practice. When a life is in danger, physicians may decide to prescribe an unproven drug and monitor the patient for any potentially serious side effects. To enable such use, the U.S. Food and Drug Administration (FDA) has “approved” the careful use of HCQ under an Emergency Use Authorization (EUA). It should be emphasized that the FDA did not approve HCQ as either safe or effective to treat or prevent COVID-19. Recognizing the unique situation doctors are facing, the FDA’s emergency authorization is for the “unapproved use of hydroxychloroquine” supplied from the nation’s stockpile but only for hospitalized adults and adolescents “for whom a clinical trial is not available, or participation is not feasible”.
Hydroxychloroquine has also caused division within the White House, media reported, after the US president, Donald Trump, hyped it as a “game changer” in treating the virus. The White House infectious disease expert warned Trump that evidence for the drug was only anecdotal and far from proven.
Dr Sacha Stelzer-Braid, a senior scientist in the virology research lab at the University of New South Wales and the Prince of Wales Hospital, said while laboratory studies using hydroxychloroquine to inactivate the virus look promising, authorities still needed to be cautious about the possible use of the drug to shorten the duration of infection or even possibly prevent infection, if used prophylactically in healthcare workers, for example.
She opines that it sounds like part of the stockpile will be used for these clinical trials in the first instance, which is a wise move. At the moment we don’t have any antivirals that we can use against the virus, so I can understand the move to acquire a drug that has preliminary evidence as possibly effective. However, I think we still need to be careful and observe our usual protocols of clinical trials, albeit at a more accelerated rate than usual.Nations need to wait for the results of proper clinical trials to see whether the in vitro laboratory results translate to having any effects in humans, she said.
Since Hydroxychloroquin is not an assured, accurate and tested medicine, the only and absolute medication and treatment using it can’t stop death. The treatment will need supportive medicine for every symptoms and a holistic coordinated treatment method must be followed until a proven drug developed.
*Chandan Kumar Duarah is a Science Journalist and former Fellow of Robert Bosch Stiftung, Germany