On Monday, the US Food and Drug Administration revoked its Emergency Use Authorization that allowed doctors to prescribe chloroquine and its derivatives to treat SARS-CoV-2 infections. The move comes in response to a growing body of data that indicates the drugs have little effect on the progression of COVID-19 but stop all the well-known side effects. But the politics behind these drugs, which have a user list that includes President Donald Trump, will likely continue to drive debate long after this decision.
FDA and soap opera
US law allows the FDA to approve emergency use of therapeutics under a specific set of circumstances. In late March, with a few small, randomized studies suggesting that chloroquine derivatives could improve the prognosis for COVID-19 patients, the FDA decided that the potential benefits outweigh the known risks and gave the drugs a Use Authorization. Emergency. This decision comes after doctors started prescribing the drugs off-label, leading to shortages. The drugs are normally used to treat malaria and autoimmune diseases.
Over time, however, supporting evidence fails to build, and known side effects—which include the drugs’ ability to cause potentially fatal arrhythmias in susceptible patients—continue to be a problem. In response to some fatal cases, the FDA updated its Emergency Use Authorization to indicate that the drug should be used only in the context of a clinical trial or in hospitals, where treatment is available to immediately identify and treat any issue caused by group of drugs. the effects.
The emergency order became a political issue early on, especially since President Trump publicly encouraged taking the drugs on multiple occasions. But the politics reached new levels in June, when the former director of the Biomedical Advanced Research and Development Authority, Rick Bright, alleged that he was fired from the agency in retaliation, at least in part because he tried to stop using chloroquine. – toxic sources when the evidence is strong. In mid-June, when Light testified to Congress, there was a partial push to protect the use of chloroquine. Soon after, Trump announced that he took the drugs after several White House employees tested positive for SARS-CoV-2; he wrote one of the studies suggesting that it is not valid as an “Anti-Trump Statement”.
Complicating matters further, a separate study showing the effect of lethal side effects was withdrawn in early June due to issues with data availability.
Some solid data
But throughout the game, strong evidence is being learned. On Monday, the acting director of the Advanced Biomedical Research and Development Authority (and Rick Bright’s replacement), Gary Disbrow, requested that the FDA rescind the Emergency Use Order. FDA answer immediately and he agreed to do so. “Today’s request to cancel is based on new information, including the results of clinical trial data, which led BARDA to conclude that this drug may not be effective in treating COVID-19,” the FDA decision reads, and the drug’s potential benefits for such use does not exceed known and substantial risks. “
The key contributor we refer to for this decision is UK’S BELIEF test, which conducted large-scale clinical trials of potential COVID-19 treatments. It tracked 1,500 patients receiving hydroxychloroquine and compared their results with more than 3,000 who received standard treatment. Mortality decreased somewhat in those who did not receive the drug, although the result was not statistically significant. No differences were found in measures such as length of hospital stay or need for ventilation, either. Other, smaller studies also failed to show a clear effect.
Meanwhile, known side effects continue to be a problem. The FDA investigated its Adverse Event Reporting Program and found more than 100 cases of serious cardiac side effects, mostly in patients who took an additional drug that worsened the effects of chloroquine. About a quarter of these cases are fatal.
The FDA is not alone in doing so. The RECOVERY trial has already completed the part of its work involving chloroquine. And in a press conference of the World Health Organization today, the director of the WHO Health Emergencies Program indicated that the organization will review the use of chloroquine in it. Unity test at the meeting scheduled for Thursday.
It is likely that most other countries testing the drugs will follow suit. Given the temporary position of the head of the Biomedical Advanced Research and Development Authority and the ongoing criminal case by the former head, it is also possible that the politics is not over yet.