Donald Trump and his administration are putting major pressure on the FDA to allow a decades-old flu drug to be used as a possible treatment for COVID-19.
However, according to a recent investigation by Politico the Trump administration is pushing for this drug to be used despite health experts raising major concerns about the risks that come with the drug as well as the fact that there is very little evidence that the drug even works.
The drug, Avigan, has been repeatedly praised by Japanese Prime Minister Shinzo Abe as a possible coronavirus treatment. Japan has just begun clinical trials on the drug, which is produced by the Japan-based company Fujifilm. However, regulators across the globe have spoken out with concerns about risks connected to the drug. Those risks include severe birth defects. Experts state that China’s data on the drug is extremely insufficient.
This is not the first time that Trump has embraced unproven drugs as a cure to the coronavirus. He also touted a “hunch” he had about an anti-malaria drug. The FDA rushed to get the drug authorized this week for “emergency use” despite little evidence the drug would be useful.
Now the White House National Security Council is also pushing for the U.S. government to accept donations of Avigan from Japan. In order to do that the FDA would have to grant an emergency-use authorization.
Reportedly Fujifilm, the FDA, and HHS have spent weeks discussing potential clinical trials of Avigan in the United States an internal summary of the deliberations reviewed by POLITICO revealed.
According to a Trump administration official, the situation is “unusual”, and some NSC officials seem to be determined to help Trump work around the regulatory system to find a coronavirus cure and that issue has many U.S. officials feeling trapped in the middle.
“There are a lot of concerns about side effects,” one official stated about Avigan.
Health officials have repeatedly rejected Avigan in the United States. Earlier this month South Korea officials declined to use the drug in their nation’s response to the coronavirus and cited serious side effects and insufficient evidence for their response.
“Avigan has not only not shown efficacy during test studies but also there is no data on clinical trials conducted on patients,” Oh Myoung-don, a South Korean infectious disease expert stated.