Trials needed for anti-malaria drug, experts say

Stores across US run out of stock after Trump calls medicine game changer

President Donald Trump has touted it as a "game changer" in treating coronavirus patients. New York state has started clinical trials of it. Several countries, including Bahrain, are already using it to battle the virus.

Pharmacists in New York, Los Angeles and Chicago and other cities say the drugs are out of stock following news of it being a potential treatment. It is hydroxychloroquine and Azithromycin, and what has sparked the rush for the drugs was a tweet from Trump.

"HYDROXYCHLOROQUINE &AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains-Thank you! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents," he tweeted on March 21.

Within days of Trump expressing his support for the drugs, New York Governor Andrew Cuomo announced his state had received approval by the Food and Drug Administration to carry out experimental trials. "There's a good basis to believe they could work," he said.

Pharmacists nationwide have said the drug is out of stock after news of it being a potential treatment spread. Two major pharmaceutical companies-Teva Pharmaceuticals and Mylan Inc-said they would ramp up production of the medicine in case it is found to work.

But scientists, researchers, drug regulatory bodies and epidemiologists-including Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House coronavirus task force-disagree. They have raised a caution flag: They must first undergo rigorous scientific testing before use.

"The information that you're referring to specifically is anecdotal… It was not done in a controlled clinical trial. So you really can't make any definitive statement about it," he said at the White House news conference after Trump mentioned it.

Besides Trump's tweet, chloroquine also gained a lot of attention after a study of 36 COVID-19 patients published March 17 in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding Azithromycin into the mix "was significantly more efficient for virus elimination", the researchers said.

Isaac Bogoch, a University of Toronto infectious disease specialist, told CNBC that many people saw the French study as helpful but that it wasn't "even close to being conclusive".

Last week, Nevada banned prescriptions of the drugs for the coronavirus until the results of rigorous clinical trials are known. "We must deal with facts, not fiction," Nevada's chief state medical officer, Ishan Azzam, said.

Nevada is one of several states trying to stop the rush for the drugs that they say has depleted supply for people who need them for established uses, including rheumatoid arthritis and lupus.

Cuomo also issued an executive order limiting new prescriptions of the anti-malarial drugs to patients with previously approved FDA conditions and to coronavirus patients participating in the New York statesponsored experiments.

According to the Centers for Disease Control and Prevention, chloroquine along with hydrochloroquine are anti-parasite, anti-inflammatory drugs.

Chloroquine is a decadesold drug that was approved by the FDA in 1949 to treat malaria. Its derivative, hydroxychloroquine, is often used to treat autoimmune disorders, including rheumatoid arthritis and lupus.

But the FDA hasn't approved them to fight COVID-19, and last week the agency said it is still determining whether they can be used to treat patients with mild to moderate COVID-19.

"Do not take any form of chloroquine unless prescribed to you by a healthcare provider and obtained from legitimate sources," FDA Commissioner Dr Stephen Hahn has warned.

In Arizona, a man who took chloroquine phosphate believing it would protect him from the coronavirus, died. His wife also took some and is in critical condition, according to NBC News.

The toxic ingredient they consumed wasn't the medication form of chloroquine, used to treat malaria in humans. Instead, it was an ingredient listed on a parasite treatment for fish.

The man's wife told NBC News she had watched televised briefings during which Trump talked about the potential benefits of chloroquine.

"I had (the substance) in the house because I used to have Koi fish (ornamental species of fish)," she told the network. "I saw it sitting on the back shelf and thought, 'Hey, isn't that the stuff they're talking about on TV?'"

In China, a report in the Zheijang University journal showed that 30 patients in a study by researchers from the department of infection and immunity at the Shanghai Public Health Clinical Center who took the drug didn't battle the coronavirus any better than those who didn't.

Dr William Haseltine, a former Harvard Medical School professor, told CNN the study from China showed "it's unlikely that the drug will work".