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Rush to approve remdesivir highlights public health failings

Politicians are seizing on anything which seems to help COVID-19 fight

| Japan
Filled vials of remdesivir at a Gilead Sciences facility in La Verne, California, pictured on Mar. 11: many small clinical trials have been carried out. (Handout photo from Gilead Sciences)   © Reuters

Andy Crump is a consultant at the Medical Governance Research Institute and a visiting professor at Kitasato University, Keio University and St Luke's International University in Tokyo.

The days when we could unquestioningly trust science and scientists are long gone. If anything, the rush to approve medicines without proper testing for the COVID-19 pandemic should give us even less faith in how our drug approval procedures and public health systems are run. Take the case of the antiviral drug remdesivir.

Remdesivir was discovered and developed by the U.S. pharmaceutical company Gilead Sciences, initially as a possible treatment for Ebola disease, but hopes arose in April that it could be used against COVID-19. On April 10, the New England Journal of Medicine published a study showing remdesivir's effectiveness in treating 36 of 53 COVID-19 patients with severe symptoms.

Nearly three weeks later, Dr. Anthony Fauci, Director of the U.S. National Institute of Allergy and Infectious Diseases, said that preliminary findings from a clinical trial of more than 1,000 patients indicated that those taking remdesivir recovered in 11 days on average, rather than 15 days for those taking a placebo. Interim results from the NIAID trial at the end of May confirmed this, but found the drug seemed to have virtually no impact on Asian patients and worked best on the young (18-40).

Following pressure from media outlets after this good news, the U.S.'s Food and Drug Administration announced an emergency approval on May 1 that the drug would be available for "compassionate use" for treatment of patients hospitalized with advanced COVID-19.

There was a similar move in Japan. On April 27, Prime Minister Abe Shinzo said that remdesivir would be approved in Japan "soon" for the treatment of patients with serious COVID-19 disease; approval duly arrived on May 8.

The problem is that there has been conflicting information on remdesivir over the past few weeks in a relatively unscientific rush to find a successful therapy to combat COVID-19. Many small clinical trials, without including proper control groups to validate the findings, have been carried out -- but politicians under pressure have only focused on the good news.

Japan's health minister Katsunobu Kato meets the press after the government approved the use of remdesivir for new coronavirus patients on May 7; the problem is there has been conflicting information on the drug.    © Kyodo

The study published in the New England Journal of Medicine on April 10 said that, before the trial, "no therapy" had demonstrated any effectiveness in COVID-19 patients. But this was not correct. In March, based on evidence from proper, scientifically sound clinical trials carried out in China, Zhang Xinmin, head of the China National Center for Biotechnology Development, reported that favipiravir, or Avigan, had been approved for the treatment of COVID-19 patients.

Objectively, the New England Journal of Medicine study on remdesivir was not up to the usual standard expected for clinical trials. It did not collect viral load data to confirm the antiviral effects of remdesivir nor was it clear on whether the known side-effects of the drug, notably harm to the liver or kidneys, occurred. The authors said that the "safety and side-effect profile of remdesivir in patients with COVID-19 require proper assessment in placebo-controlled trials."

The study lacked a proper randomized control group and of the original 61 patients included in the trial, for some unexplained reason, the data for eight "could not be analyzed." It should also be noted that the study was financially supported by Gilead Sciences, the U.S. pharmaceutical company that manufactures remdesivir.

This rush means that negative news is ignored. On April 29, the prestigious Lancet medical journal published the results of a comprehensive, properly randomized, double-blind, placebo-controlled, multicenter trial of remdesivir. The trial, carried out in China on 237 adult COVID-19 patients with advanced symptoms, concluded that "remdesivir was not associated with statistically significant clinical benefits."

The drug did not speed up time to clinical improvement. In addition, adverse side effects were observed in two-thirds of the patients receiving remdesivir, causing the trial to be stopped prematurely.

The authors concluded that remdesivir "did not provide significant or antiviral effects in seriously ill patients with COVID-19." However, they did observe some clinically meaningful differences and suggested that higher doses or combinations with other antivirals could be beneficial but that proper studies would be required to establish this. There were no financial sponsors of the study.

The unseemly and unscientific rush to promote remdesivir, irrespective of whether it will eventually prove successful or not, is extremely concerning -- although not unexpected, as the West has constantly ignored Chinese science and medical interventions, even if they are evidence-based.

There is evidence from China that favipiravir, plasma therapy and traditional Chinese medicine can all be used for successful treatment of COVID-19 patients, but for various reasons most Western countries do not accept this evidence. Instead, they have begun time-consuming clinical trials to see if these options work -- even while tens of thousands of people in the very same nations have already died.

Whether or not remdesivir is of use in treating COVID-19 patients remains a matter of conjecture. Certainly, the scientific evidence remains inconclusive, as well as possibly being influenced by unwanted biases. All of this does not offer much comfort to those with loved ones suffering from COVID-19.

Worse still, it further reduces public trust in science, the medical community and the authorities making decisions that determine what is available to us all through national health services.

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