Updated: Aug 28, 2020
On August 23, 2020, The President of the United States and FDA announced an 'emergency authorization' of a drug that will be used as a treatment for COVID-19. This is coming a day after the President accused the regulatory body of playing politics with the therapy's authorization.
The FDA held off on their course of action the previous week due to worries brought up by government researchers who believe that the proof of the drug's effectiveness is not sufficient. President Trump went on to accuse the body of delaying the process for political reasons, even though his claim had no evidence. The sudden announcement did not show that the FDA has gotten new medical records, which would validate the use of the therapy.
As a result, specialists and former officials have criticized the FDA for bowing to the President's demands. It is widely known that the President has been seeking the emergency approval of hydroxychloroquine to treat the pandemic regardless of limited data. The regulatory body had earlier pulled the support after discovering it offered no value following clinical studies, but Trump protested against the reversal. An anonymous source from the White House Coronavirus Task Force revealed to CNN that new evidence had been checked by the FDA to advise its EUA position. This representative has not examined the information in person. They noted that the FDA is not obligated to communicate with anyone outside the federal regulatory body regarding its judgment.
The name of the therapy/medication is known as convalescent plasma. It is taken from the blood of patients that have successfully recuperated from Covid-19. The FDA laid out a direction for researchers at the end of March to continue convalescent plasma with people with the novel flu and survey its effect. It has already been used in treating over 60,000 patients with Covid-19. Nevertheless, Convalescent plasma is low in supply. This is because, just like blood, it must be donated before it is supplied. And while there are positive signs from some tests, results on convalescent plasma for treating the virus are not valid for randomized clinical trials. A few of those tests are ongoing. Specialists believe there needs to be more data before it is approved.
One of the fears expressed by scientists is related to the Thalidomide Tragedy in 1960. Thalidomide was sold to the world, which, at that time, depends mainly on painkillers and sleeping pills. This is because in a post-war era when sleeplessness was predominant. In some EU countries, the demand for tranquilizers was even higher. The perceived protection of thalidomide, the only semi-barbiturate drug known at the time, gave the drug widespread appeal. Unfortunately, disaster accompanied its launch, instigating the origins of the thorough clinical trials and supervising measures in place at the US FDA today.