Drug Touted By Trump Linked To Increased Risk Of Death In Coronavirus Patients

PMH

Doctors performed a retrospective analysis of 96,000 patients from across the globe, the largest analysis to date.

The Washington Post reports that a team of doctors published a study on the effects of hydroxychloroquine and azithromycin on COVID-19 in the [Lancet](https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20%2931180-6.pdf) journal on May 22.

  • The study is based on a retrospective analysis of medical records concerning treatment of hospitalized COVID-19 patients using the antiviral hydroxychloroquine and the antibiotic azithromycin.
  • The analysis examined over 96,000 patients and is the largest study on hydroxychloroquine and COVID-19 to date.
  • For patients given hydroxychloroquine, there was a “34% increase in risk of mortality and a 137% increased risk of a serious heart arrhythmias.”
  • Patients given both hydroxychloroquine and azithromycin experienced “a 45% increased risk of death and a 411% increased risk of serious heart arrhythmias.”
  • Michael Felburn, a spokesperson for the Food and Drug Administration, said that while the agency typically “does not comment on third-party research,” new data about effectiveness could lead to revoking an emergency use authorization.
  • The Administration had previously provided an emergency use authorization approving the drug for critically ill patients who were hospitalized or for whom no clinical trial was available.

Hydroxychloroquine is normally used as an antimalarial drug, and it has also been used to treat lupus and rheumatoid arthritis. Anecdotes about hydroxychloroquine’s effectiveness as a COVID-19 treatment have circulated, and President Donald J. Trump called it a “game changer.”

  • When doctors in March saw a large wave of patients and had little to offer, some offered hydroxychloroquine because it was widely available, had strong antiviral properties, and was thought to be relatively benign.
  • However, after “at least 13 studies,” including clinical trials and retrospective analyses, “Evidence of any benefit, such as viral clearance or improved symptoms” as anecdotes have suggested, “has been almost nonexistent.”
  • Additionally, presumptions about hydroxychloroquine’s safety were largely based on its antimalarial and lupus treatment use “at lower doses than were being used at hospitals during the early days of the surge in patients in the United States and mostly in patients who were healthy.”
  • Many hospitalized COVID-19 patients already had heart problems that may have made them more susceptible to arrhythmia from hydroxychloroquine. Doctors are also finding that COVID-19 may attack the heart as well, whether directly or indirectly, leaving patients even more vulnerable.

Because the analysis is an observational study, it strictly speaking shows correlation rather than cause and effect. However, the scale of the study has made it persuasive to multiple health care professionals and researchers.

Eric Topol, a cardiologist and director of the Scripps Research Translational Institute, said, “It’s one thing not to have benefit, but this shows distinct harm,” and asked for researchers should reconsider the ethics of further studies.

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