(CNN) – The President of U.S, Donald trump, assured that he has lobbied the Food and Drug Administration (FDA) to eliminate the barriers to obtaining therapies against the coronavirus for patients.
According to the president, a drug currently used to treat malaria – hydroxychloroquine – could be available almost immediately to attack the virus.
“It’s been around for a long time, so we know that if things don’t go as planned it’s not going to kill anyone,” Trump pointed out to the press at the White House.
“We have to remove all or many of the barriers that were unnecessary, and they have done so to achieve the rapid deployment of safe and effective treatments, and we believe we have some good responses,” added the president.
However, FDA Commissioner Stephen Hahn carefully nuanced Trump’s comments about the work his team is doing to develop treatments for the coronavirus.
“The FDA is committed to continuing to provide regulatory flexibility and guidance, but let me clarify one thing: FDA’s responsibility to the American people is to ensure that products are safe and effective,” he warned.
And he added that the agency is expanding its work against possible therapeutic options.
“We need to make sure that in this sea of new treatments we will deliver the right medicine to the right patient in the right dose and at the right time,” said Hahn, explaining that the right medicine may be available but may not be in the right dose, “and that can do more harm than good. ”
So part of that is exploring medicines that “are already approved for other indications,” Hahn added, referring to the president’s comments on chloroquine.
“That is a drug that the President has ordered us to take a closer look at to see if an expanded use approach could be done and see if that benefits patients. And again, we want to do it in the context of a clinical trial, a large and pragmatic clinical trial to collect that information, “he added.
Hahn also explained the process of convalescent plasma, which is related to isolating the blood of those who have survived the coronavirus and have the correct antibodies. A concentration of that could treat people infected with the virus.
As for time, Hahn said, “In the next two weeks, we will have more information that we are really pushing to try to accelerate … and that will be a bridge to other therapies that will take us three to six months to develop. And this is a continuous process: there is no beginning or end ”.
He also noted that a vaccine is currently being tested and is expected to take “12 months.”
Preliminary evidence from human cells suggests that chloroquine – used to treat malaria and autoimmune diseases – may have some activity against the coronavirus. Doctors in China, the United States, and other countries have used this medicine experimentally in patients with covid-19, but there is still insufficient clinical evidence that it is effective in humans.
The drug, generally considered safe for most patients, can have side effects including seizures, nausea, vomiting, deafness, vision changes, and low blood pressure.
When asked about chloroquine last month, Dr. Janet Diaz of the World Health Organization said, “There is no evidence that it is an effective treatment at this time. We recommend that therapies be tested under ethically approved clinical trials to demonstrate efficacy and safety. “
At the time, she noted that the priority drugs in WHO’s research and development efforts were antivirals, another type of drug that includes remdesivir, which is also being tested in clinical trials in China and the United States.
Following Trump’s announcement Thursday, CNN Chief Medical Correspondent Dr. Sanjay Gupta said it was important to “be a little cautious” when learning about the medications being tested to treat the coronavirus.
“Everyone wants to be hopeful,” he told CNN’s John King on the “Inside Politics” show, “but we need to be a little cautious when hearing about these types of medications. They must be proven like everything else. ”
Gupta added that “the scientific community is always at that tipping point of hope and honesty, but we have to be honest here, we just don’t know enough and I don’t want people to have false hope here.”
CNN’s Jamie Gumbrecht, Minali Nigam, Michael Nedelman, Nadia Kounang and Devan Cole all contributed to this report.
– .
