On June 22, Science reported on the political and medical fallout of chloroquine (a hydroxychloroquine congener) research. In April, Dr. Marcus Lacerda and his team at institutions including the Heitor Vieira Dourado Tropical Medicine Foundation in Manaus, Brazil, published their study showing that the drug increases mortality in COVID-19 patients. In response, they’ve been accused of both negligence and even deliberate malfeasance for using very high doses and “poisoning” subjects, some perhaps on the paranoid side believed in order to make Presidents Bolsonaro and Trump look bad. They have faced social media attacks and a wide range of personal attacks. After Bolsonaro’s son tweeted an article calling the researchers “left-wing medical activists,” they started to get death threats against them and their families. Next, the federal prosecutor started an inquiry, which is now ongoing.
Peter Kremsner, of the University of Tübingen, Germany, has called the doses used, “dangerous and definitely too high.” Others have argued that the high doses were a “calculated risk” at a time when COVID-19 urgency was high and effective-levels unknown. The study included 440 people, and some were given 600 mg chloroquine twice a day for 10 days totaling 12 grams. The trial’s safety team saw a high death rate in this group, and they requested that this arm be stopped. The arm was stopped early, and the results reported to warn others. It appears that one factor in the high dosing may have been a mistake in equating chloroquine base and chloroquine phosphate. Lacerda “says the team did a wide literature review before making its dose decision,” and he is quoted directly: “The day someone tells in your social media, that they’re going to kill your children to make you suffer the way you made other people suffer, you will understand what I’ve been through.”
Lancet Joins Discussion
On May 27, Lancet weighed in on this tale in “Death threats after a trial on chloroquine for COVID-19.” Dr. Lacerda is quoted saying, “we used a high dose of chloroquine that has been used before,” and Lancet notes that this “same high dose was previously used to treat oncological patients for periods much longer than 10 days; it was also used in China with COVID-19 patients.” According to Lacerda, once JAMA published the paper, “the threats stopped.” This shows “that publishing the study in a peer-reviewed high-impact journal may have shielded the researcher and his family.” Of course, Lancet had its own strange zombie moment just blindly accepting observational research from a non-name Chicago operation called Surgisphere. From our perspective at TrialSite News, it is probable that the research dosing was in fact a legitimate calculated risk. But negligence cannot be completely ruled out, and the whole story reminds us that we need to be careful that our urgency for a COVID-19 treatment does not lead to a lowering of ethical or technical standards in research. We believe that patients round the world have more things in common than not. We want safe, effective and economical treatments. TrialSite News won’t stop until such treatments are here.
