KEY POINTS

  • The federal government is trying to get rid of 63 million doses of hydroxychloroquine
  • The FDA on June 15 stopped its emergency use authorization for the drug
  • It said hydroxychloroquine is "unlikely to be effective in treating COVID-19 for the authorized uses"

The United States has 63 million worthless doses of hydroxychloroquine, which was touted by President Donald Trump as the "miracle cure" for COVID-19 until the Food and Drug Administration (FDA) on June 15 said the federal government would no longer recommend its use against the disease.

The reason: hydroxychloroquine is "unlikely to be effective in treating COVID-19 for the authorized uses." The FDA also said the known benefits to using hydroxychloroquine "no longer outweigh the known and potential risks” in light of ongoing serious cardiac adverse events and other side effects.

This determination led the FDA to terminate its emergency use authorization (EUA) for the anti-malarial drug in a stinging rebuke to Trump, who claimed to have used the drug for two weeks to prevent infection by COVID-19.

The FDA's decision to grant the drug an EUA was widely criticized by the medical community as unnecessary, given a lot was already known about the drug, which was approved for medical use in the U.S. in 1955. Many infectious disease experts were united in saying there was never any evidence hydroxychloroquine could cure COVID-19.

FDA Commissioner Dr. Stephen Hahn said the decision to authorize hydroxychloroquine in March "was based on evaluation of the EUA criteria and the scientific evidence available at that time." Due to Trump's orders, the federal government began stockpiling massive doses of hydroxychloroquine starting March. Trump began promoting the drug after hearing about a French study claiming it cured COVID-19.

The study, which involved only 20 people, has since been withdrawn for numerous ethical violations. Trump then began touting hydroxychloroquine as "very encouraging" and "very powerful" and a "game-changer."

Most of the doses now stored at the Strategic National Stockpile appear to have been donated by multinational drug firms Novartis International AG from Switzerland and Mylan N.V. from The Netherlands. The stockpile also includes two million doses of chloroquine, a related drug donated by German pharma firm, Bayer AG. The U.S. Department of Health and Human Services (HHS) distributed 31 million doses before the FDA revoked the drug's EUA.

"HHS is working with the companies that donated the product to determine the available options for the product that remains in the Strategic National Stockpile," said HHS spokesperson Carol Danko.

Both hydroxychloroquine and chloroquine can produce potentially serious side effects, particularly heart arrhythmia
Both hydroxychloroquine and chloroquine can produce potentially serious side effects, particularly heart arrhythmia AFP / GEORGE FREY