India boon in Trump use of malaria drug
NEW DELHI, May 20, (AP): US President Donald Trump’s declaration that he was taking an antimalarial drug of dubious effectiveness to help fend off the coronavirus will be welcomed in India.
Trump’s previous endorsement of hydroxychloroquine catalyzed a tremendous shift in the South Asian country, spurring the world’s largest producer of the drug to make much more of it, prescribe it for front-line health workers treating the virus and deploy it as a diplomatic tool, despite mounting evidence against using the drug for COVID-19.
Trump said Monday that he was taking hydroxychloroquine as a measure of protection against the virus. The US Food and Drug Administration, however, has cautioned against using it outside of hospitals because of the risk of serious heart problems.
India’s policy on the decades-old drug, used to prevent malaria and treat lupus and rheumatoid arthritis, drastically changed after Trump tweeted in March that the drug, used together with an antibiotic, could be “game changers” in the fight against the pandemic. India’s health ministry quickly approved it as a prophylactic for health care workers and others at high risk of infection, and as a treatment for critically ill patients.
Amid concerns from some public health experts that Trump’s example could send more people to misuse the drug, White House press secretary Kayleigh McEnany said Tuesday that “tens of millions of people around the world have used this drug for other purposes,” including malaria prophylaxis. She emphasized that “any use of hydroxychloroquine has to be in consultation with your doctor. You have to have a prescription. That’s the way it must be done.” The drug is also prescribed for some lupus and arthritis patients. At the White House, Trump said his doctor did not recommend hydroxychloroquine to him, but that he requested it from the White House physician.
“I started taking it, because I think it’s good,” Trump said. “I’ve heard a lot of good stories.”
The White House physician, Dr Sean Conley, said in a statement released through the press office that, after “numerous discussions” with Trump about the evidence for and against using hydroxychloroquine, “we concluded the potential benefit from treatment outweighed the relative risks.”
Senate Democratic leader Chuck Schumer called Trump’s remarks on the drug dangerous.
“Maybe he’s really not taking it because the president lies about things characteristically,” Schumer said on MSNBC. He added: “I don’t know whether he is taking it or not. I know him saying he is taking it, whether he is or not, is reckless, reckless, reckless.”
At least two White House staffers tested positive for COVID-19 earlier this month, sparking concerns about the steps taken by the administration to protect the president and sending Vice President Mike Pence and other officials into varying forms of self-isolation.
The White House has since mandated that those in the West Wing wear face coverings and has introduced daily testing for the virus for the president, vice president and those they come in close contact with. Trump says he continues to test negative for the coronavirus.
Trump last underwent an “interim” medical checkup in a November visit to Walter Reed National Military Medical Center that was not noted on his public schedule. His last complete physical took place in February 2019.
Several prominent doctors said they worried that people would infer from Trump’s example that the drug works or is safe.
“There is no evidence that hydroxychloroquine is effective for the treatment or the prevention of COVID-19,” said Dr Patrice Harris, president of the American Medical Association. “The results to date are not promising.”
People should not infer from Trump’s example “that it’s an approved approach or proven,” because it’s not, said Dr David Aronoff, infectious diseases chief at Vanderbilt University Medical Center in Nashville.
Plan
Meanwhile, officials in Mumbai even drew up a plan to administer hydroxychloroquine to thousands of slum dwellers as a preventive measure against the virus.
Indian health officials have declined repeated requests for comment, limiting communications to daily health briefings, the last of which occurred May 11.
The rules say that drugs such as hydroxychloroquine be used only after a rigorous scientific and ethical review, continued oversight by an ethics committee and ensuring informed consent — none of which happened with HCQ, according to Dr Amar Jesani, a medical ethics expert.
The Mumbai proposal was ultimately shelved amid questions of the ethics of administering HCQ, as the drug is known, without first subjecting it to clinical trials. Still, the Indian government has recommended more and more people use it, contravening 2017 rules for emergency use of untested drugs, Jesani said.
India initially banned HCQ exports, but lifted the ban after Trump threatened “retaliation.” At the same time, India’s government ordered manufacturers to ramp up production from 1.2 million to 3 million pills a month — causing company shares to skyrocket. From the US to Australia, sales jumped.
Officials have even said that Indian plantations could increase the growing capacity of cinchona trees, whose bark contains the compound quinine, which has been used to treat malaria since the 1860s. Quinine can also be made synthetically.
The Indian government itself purchased 100 million HCQ pills, according to government data, to distribute to states and donate to countries including Afghanistan, Myanmar and the Dominican Republic.
India is the world’s largest producer of generic drugs, a fastgrowing industry that has brought down pharmaceutical prices globally. During the HIV/AIDs crisis, India played a similar role as in the coronavirus pandemic, boosting global supplies of lifesaving drugs.
The problem this time, experts say, is that the hydroxychloroquine hype is based on a flimsy study, with little to no evidence that it prevents or treats COVID-19.
Still, a sharp rise in demand has reduced supplies for patients with lupus and rheumatoid arthritis.
India’s hurried guidance has also impeded scientific trials that could determine whether the benefits of taking HCQ outweigh the risks.
Trial
“We should do a trial. I think that is the right way to come to answer on this question. But the (government) made our job harder,” said Dr Bharath Kumar, whose team has proposed a trial.
Meanwhile, evidence against using HCQ for the coronavirus is growing.
A US study of 368 patients in veterans’ hospitals, the largest study yet examining HCQ’s value as a coronavirus antidote, found no benefits and even more deaths among those given the drug.
The Indian government’s own assessment of 19 drugs found that HCQ wasn’t the most promising. A task force noted that while HCQ was readily available, the strength of scientific evidence for the mechanism of action was fairly low.
With more than 101,000 cases and 3,163 deaths, the coronavirus hasn’t yet overwhelmed India’s limited health care system. But that’s starting to change in some hot spots as a stringent weekslong nationwide lockdown begins to ease, allowing for greater mobility of the country’s 1.3 billion people.