Washington, Apr 22 () The plan to use much touted anti-malarial drug hydroxychloroquine for treating COVID-19 patients has received a setback with more deaths being reported among those who were given the drug, according to a report.
While another report suggested that there was insufficient clinical data to either recommend or oppose the use of hydroxychloroquine for treating those infected with the deadly virus.
President Donald Trump, who has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients, said that he would look into the reports.
His administration has stockpiled more than 30 million doses of hydroxychloroquine, a large chunk of which has been imported from India.
"I don't know of the report. Obviously, there have been some very good reports and perhaps this one's not a good report. But we'll be looking at it. We'll have a comment on it at some point," Trump told reporters during his daily White House news conference on coronavirus.
Trump was responding to a question on a study released by a group of scientists on use of hydroxychloroquine with or without antibiotic azithromycin for 368 COVID-19 patients.
The unreviewed study submitted to New England Journal of Medicine for publication and posted online found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalised with COVID-19.
"An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone," said the study that was funded by the National Institute of Health or NIH.
NIH in its report 'Therapeutic Options for COVID-19 Currently Under Investigation' said that there are insufficient clinical data to either recommend or oppose using chloroquine or hydroxychloroquine for treatment of COVID-19.
If chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval, it said.
The panel of NIH experts recommended against the use of the combination of hydroxychloroquine and azithromycin because of the potential for toxicities.
US Food and Drug Administration Commissioner Stephen M Hahn said that no final decision has been taken as yet.
"I've mentioned from this podium and in other venues before, what FDA is going to require is data from clinical trials, randomised clinical trials, hydroxychloroquine/placebo, to actually make a definitive decision around safety and efficacy," he told reporters.
The first one is a small retrospective study at the VA. "And similar to the data we talked about before with the French study, this is something that a doctorate would need to consider as part of a decision in writing a prescription for hydroxychloroquine," he said.
"But the preliminary data are helpful to providers. I want to ask them (doctors) to incorporate the data as we have it come forward. It's not definitive data. It doesn't help us make a decision from a regulatory review."
"But doctors should incorporate that in the decision-making they make on a one-on-one basis," Hahn said in response to a question.
Congressman Bill Pascrell said the report analysing hydroxychloroquine as a potential COVID-19 treatment at veterans hospitals is a bombshell indictment of the damage Trump and his administration does to Americans by putting politics before science.
"The world class medicine and doctors we enjoy today are the fruit of generations of painstaking work by our ancestors. Evidence-based science is the only way out of this crisis, not unproven miracle therapies personally favored by Donald Trump," he said.
"Trump's frequent touting of this treatment was deeply irresponsible, and may have heaped unnecessary pain and suffering, not to mention false hope, upon Americans struck by this terrible illness."
"I have repeatedly warned the FDA about the danger of prizing Trump's political pressure over scientific process. Unless we are guided by science and science alone, we will have more unnecessary deaths on our hands," Pascrell said. LKJ RHL