Week in review: unethical research, hydroxychloroquine RCT, and structural racism

Hydroxychloroquine remains in the news. The Lancet retracted the study I wrote about 2 weeks ago, a large, multinational review of hydroxychloroquine's effectiveness for COVID-19, due to serious concerns about data integrity. After the study's publication, Australian journalists noticed that the study's Australian mortality data did not align with Johns Hopkins University data collected during the same period.  The study data was collected by a company called Surgisphere, and further journalistic digging revealed that "several of Surgisphere’s employees have little or no data or scientific background:"

“Surgisphere came out of nowhere to conduct perhaps the most influential global study in this pandemic in the matter of a few weeks....It doesn’t make sense...It would require many more researchers than it claims to have for this expedient and [size] of multinational study to be possible.” 

Some of the study authors then requested that Surgisphere submit its data to independent peer reviewers. When Surgisphere reportedly refused to do so, they requested retraction of the study. It's disheartening at any time to uncover unethical research practices only after publication, let alone during a global pandemic, when clinicians and patients are desperate for data to guide decisions.

Meanwhile, a more reputable RCT in the United Kingdom (the RECOVERY trial) halted its hydroxychloroquine arm this past week. In just the last 3 months, researchers have enrolled over 11,000 patients in the UK into this trial, which also includes lopinavir-ritonavir, dexamethasone, azithromycin, tocilizumab, convalescent plasma, and "usual care" arms. The study's independent data review monitoring committee notified the researchers that there was no difference in 28-day mortality rates between participants taking hydroxychloroquine and participants receiving usual care (25.7% hydroxychloroquine vs. 23.5% usual care; hazard ratio 1.11 [95% confidence interval 0.98-1.26]), leading the research team to discontinue randomizing patients to receive hydroxychloroquine. It seems far less likely that peer review will uncover any scruples with this rigorously conducted trial, and perhaps the question of hydroxychloroquine's benefit will finally be put to rest despite the Surgisphere fiasco.

A final word for this week: The American Academy of Family Physicians released a statement this week strongly condemning racism. As family physicians, we see daily that structural racism continues to result in profound health inequities in the US, and thousands of physicians across the US participated in White Coats for Black Lives rallies this past week. If you're looking for steps to take toward dismantling this legacy, you can find data about cultural competence training in this AFP Cochrane for Clinicians article, learn about implicit bias in this FPM article, and take practical steps toward "Achieving a More Minority-Friendly Office" here. #BlackLivesMatter.