New York moved to begin trials Tuesday, procuring 70,000 doses of hydroxychloroquine and 750,000 doses of chloroquine, Gov. Andrew Cuomo said. In addition Bayer, the drug maker, has donated 3 million doses of Resochin, its brand name for chloroquine, to the federal government.
So, what exactly are these drugs, and what promise do they hold?
Vital to battle against malaria
WHO includes it on its list of “essential medicines,” meaning it should be kept affordable and accessible at all times.
German scientists created the synthetic chloroquine in 1934 as part of a class of anti-malarials, MMV said, and chloroquine and DDT became “the two principal weapons in WHO’s global eradication malaria campaign” following World War II, the organization said.
It’s given to patients with rheumatoid arthritis, lupus and the blood disorder porphyria cutanea tarda, the CDC said.
‘It’s not going to kill anybody’
The reason Trump lauds the drugs is because they’ve been shown, in labs, to be effective against severe acute respiratory syndrome coronaviruses — including the SARS strain that causes Covid-19 — as well as other coronaviruses, the CDC said.
Hydroxychloroquine is being studied to determine if it can prevent the onset of Covid-19 before or after a patient is infected with the SARS coronavirus strain that causes it, and if it can be used to treat Covid-19 sufferers, the CDC said.
Because the drug has been in use for years, Trump said, it potentially poses fewer risks than a newly developed drug.
“The nice part is,” he said last week, “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 anybody.”
It is thus considered a recommended antiviral for Covid-19 treatment in China, and several countries are recommending both drugs for hospitalized Covid-19 patients, the CDC said.
Chloroquine also appears to have “broad-spectrum antiviral properties” and effects on immune response, Bayer said in its statement announcing the drug donations.
“New data from initial preclinical and evolving clinical research conducted in China, while limited, shows potential for the use of Resochin in treating patients with COVID-19 infection,” the statement said.
Evidence only anecdotal, expert said
The CDC said the combination can disrupt the heart’s electrical activity and warns against prescribing the paired drugs to anyone with chronic medical conditions, such as renal failure or hepatic disease.
Chloroquine’s side effects include seizures, nausea, vomiting, deafness, vision changes and low blood pressure. Both chloroquine and hydroxychloroquine, however, are reportedly well-tolerated in Covid-19 patients, according to the CDC.
All that said, Dr. Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases who has appeared alongside Trump at several news conferences, has said evidence of the drugs’ effectiveness is only anecdotal.
With respect to the SARS strain, the drugs’ effectiveness was never vetted in a clinical trial, he said.
The drugs may be effective against the novel coronavirus, Fauci said, but more data is needed to “show it is truly safe and effective under the conditions of Covid-19.”
‘It showed promise in the test tubes’
In a Thursday statement, the FDA said it had been working with government agencies and universities to learn whether chloroquine can reduce symptoms and stem the spread of Covid-19 in those with mild to moderate cases of the virus.
“We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate treatments,” FDA Commissioner Stephen Hahn said in the statement.
During a meeting of the coronavirus task force, Hahn called for “a large, pragmatic clinical trial to actually gather that information and answer the question that needs to be answered — asked and answered.”
The FDA is also talking with drug manufacturers about ramping up production of the drugs to handle a spike in demand and to ensure that people with life-threatening conditions such as lupus can still obtain it.
Dr. Deborah Birx, Vice President Mike Pence’s coronavirus response coordinator and another regular at Trump’s news conferences, said in a Fox News interview last week that people should not confuse the drugs showing “promise” in other countries with actual efficacy.
“That doesn’t mean that it will show promise in Americans,” she told the news outlet. “It showed promise in the test tubes. We are very interested in making sure we have eliminated red tape to make the drug available through their physicians, and study it at the same time. At the same time, we are doing clinical trials on other products we think also will show promise.”
One drug, lopinavir-ritonavir, did not show promise for treating Covid-19-related pneumonia in China, the CDC said. Another medication mentioned by Trump, remdesivir, has “broad antiviral activity,” the CDC said, but requires further study.