Eskayef Pharmaceuticals, one of the leading drug manufacturing companies of the country, has successfully produced a generic version of Remdesivir, an antiviral medication developed by the California-based biopharmaceutical company Gilead Sciences. It was originally developed to treat Ebola and its close cousin the Marburg virus, but was found to be ineffective against those infections.
Simeen Hossain, managing director of Eskayef, speaking to The Daily Star (which we should mention is part of the same Transcom family as Eskayef, a fact never mentioned in their report), said “At this crucial time in the country, we are happy to give the people the good news that we have successfully completed all the steps in the manufacturing of Remdesivir, globally recognised as the only effective drug against coronavirus.”
All procedures for production have been completed and preparations have begun from Friday (today) morning for distribution of the drug.
We feel the reporting was highly inaccurate, particularly in the context of a drug that will feature in a life-or-death situation, which behooves us as journalists to exercise even greater caution. The Daily Star in their report, among other things, said: “Last week, the US Food and Drug Administration (FDA) approved Remdesivir as a drug against coronavirus.” Actually it was not so straightforward.
Let’s look at Gilead’s own press release on Remdesivir: “Remdesivir is authorized for the treatment of hospitalized patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials....The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process. Remdesivir remains an investigational drug and HAS NOT BEEN APPROVED by FDA."
What the FDA issued for Remdesivir was an EUA - Emergency Use Authorization, not approval. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency in certain situations such as the pandemic that has severely affected the United States, which has been the world’s worst sufferer. In fact, Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. It has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are coronaviruses structurally similar to SARS-CoV-2, the coronavirus that causes COVID-19.
Two new reports have produced conflicting results on the potential effectiveness of Remdesivir in treating COVID-19. Disappointing results emerged from the first gold-standard clinical trial for the drug, which found that it did not help patients in China with severe COVID-19. Those findings were published April 29 in The Lancet medical journal. On the same day, Gilead Sciences announced positive early findings from a U.S.-designed clinical trial being conducted at 180 sites around the world. Gilead announced that the U.S. trial will show that COVID-19 patients treated earlier with remdesivir had better outcomes than those who received the drug later in the course of their illness.
It led to Dr Anthony Fauci touting its usefulness at the White House, and that made it a ‘sensation’ around the world. But even he was only able to say it could reduce the length of hospitalisation for a patient with severe COVID-19 from 15 days to 11. There is nothing as yet on its impact on lethality by the way.
It may still work- we hope it does. But we also believe it is important for us to exercise a sense of responsibility at a time like this on a topic such as this, and do all we can to put out all the facts known to us in front of our readers.