The FDA has issued an emergency use authorisation for Hydroxychloroquine and Chloroquine. After scant evidence of their effectiveness, they're being used to treat critically ill patients with Covid-19.
The Food and Drug Administration (FDA) has allowed the drugs to be donated to the Strategic National Stockpile. This stockpile is the US' largest supply of lifesaving medicines and medical supplies. These are to be used in a public health emergency that is severe enough to cause supplies to run out.
Sandoz, a company owned by Novartis (a pharmaceutical company), has donated 30 million doses of Hydroxychloroquine. Bayer, another pharmaceutical company, has donated a million doses of Chloroquine. These drugs are then to be distributed and prescribed to teenage and adult patients that have been hospitalised with the Coronavirus.
This movement to give patients the drugs has been supported by the White House and Donald Trump from the start. With Trump backing the process, the drug is being rushed out to patients with no significant proof that it is actually effective against Covid-19.
So far, in New York state, they are test-administering Hydroxychloroquine and Chloroquine to patients that are critically ill with Covid-19. Some other hospitals have added the drugs to their treatment protocols.
At a press briefing on Sunday, to reference New York state's efforts, Trump said: "Let's see how it work,". He then followed up with, "It may. It may not".
Career scientists, like Dr. Anthony Fauci from the National Institute of Allergy and Infectious Diseases, have been sceptical of the efforts of rushing the anti-malarial drugs to the ill - noting the lack of data of the drugs' efficiency against Covid-19. They were also worried that people, with other conditions that need the drugs, wouldn't have a supply.
“This is insane!” tweeted Gaetan Burgio, an Australian National University expert on drug resistance, noting what he sees as lapses in the 6-day trial, including inconsistent testing of virus levels in the patients.
Darren Dahly, a co-author of one of several critiques of the initial study and a principal statistician at the University College Cork School of Public Health, said it would be “egregious” to recommend treatments for millions of people based on such a small trial, regardless of its quality.
“The best way to know whether a medication for COVID-19 is effective is through a high-quality clinical trial,” says Joshua Sharfstein, a vice dean at Johns Hopkins University’s Bloomberg School of Public Health and a former principal deputy Food and Drug Administration commissioner. “Efforts to widely distribute unproven treatments are misguided at best and dangerous at worst.”
Although doctors regard hydroxychloroquine as relatively safe at prescribed doses for short periods, it has been associated with life-threatening cardiac side effects and suicidal behavior. “Given the toxicity of the drug, I’m afraid my government is going to kill people,” Taschner said.
More and more patients that have conditions that Hydroxychloroquine and Chloroquine treat are complaining that they cannot fill their prescriptions. Some reports have surfaced that physicians are withholding the drugs from patients and keeping it for themselves. Federal officials have privately complained that Donald Trump's focus on anti-malaria drugs has shifted the focus off of more promising therapies to treat Covid-19.
When Trump was asked whether his agencies should wait for more evidence that Hydroxychloroquine and Chloroquine are effective, the United States president emphasised the need for speed. He also alluded to disagreements with Anthony Fauci, an infectious disease specialist, who has counselled the president not to rush with unproven medicine.