After the retraction of a study on hydroxychloroquine with data provided by a Duke alum's company, a Duke study on the drug has felt ripple effects.
While studying as a surgical resident in the Duke University Medical School, which he completed in 2011, Sapan Desai founded Surgisphere, a company that initially sold medical textbooks but eventually evolved to doing data analytics for medical research. Surgisphere provided the database for a May study that reported harmful effects associated with the antimalarial drug hydroxychloroquine among patients with COVID-19, according to The Scientist.
A week after the paper was published in The Lancet, concerns arose in newspapers and on social media among the scientific community about the paper’s statistical analyses, according to The Scientist. Researchers around the world signed a May 28 open letter that detailed multiple problems with the data analysis. Readers also started questioning Surgisphere and how it collected such a vast amount of complex data in a relatively short span of time.
The Lancet published a retraction of the paper June 5, stating that one reason was Surgisphere’s refusal to transfer their dataset to a third-party for an independent peer review.
The Chronicle was unable to reach Desai or a representative of Surgisphere for comment. The Scientist reported that Desai’s spokesperson stopped communicating with them after The Lancet’s retraction.
Desai has defended his company’s work, telling The New York Times in May that his “life’s work” was to build a company that could “make the world a better place” through clinical insights.
The Times also reported that Desai was named as a defendant in three medical malpractice lawsuits in 2019. A spokeswoman told the Times that Desai “deems any lawsuit naming him to be unfounded.”
Susanna Naggie, associate professor of medicine and vice dean of clinical research in the School of Medicine, said that Duke research has become collateral damage in the Lancet paper controversy.
Naggie and Emily O’Brien, assistant professor in population health sciences, lead the Healthcare Worker Exposure Response and Outcomes (HERO) Project, which is conducted by the Duke Clinical Research Institute and funded by the Patient-Centered Outcomes Research Institute.
The HERO Project has two parts: a registry of healthcare workers that can help show how this group has been affected by the pandemic, and a randomized clinical trial that aims to identify whether hydroxychloroquine is effective in decreasing the rate of COVID-19 infection.
This project is intended to be the “largest pre-exposure prophylaxis trial of hydroxychloroquine, certainly in the United States and probably globally,” Naggie said.
However, Naggie said that after the Lancet study concluded that hydroxychloroquine had no benefit to COVID-19 patients and was associated with cardiac arrhythmias and increased mortality rates, the HERO clinical trial started experiencing enrollment difficulties.
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She said that even after the Lancet published the retraction, the damage was done. Currently, 1,300 participants are enrolled—700 shy of the original goal.
Naggie said the falsified paper caused a negative ripple effect on studies around the world. Over the course of her career as a clinical researcher, she said that she has never seen such heightened controversy surrounding a drug.
The drug has been the subject of other controversies during the pandemic, with President Donald Trump extolling its benefits—and even saying he was taking the drug himself—despite experts questioning its effectiveness.
Nonetheless, there is a silver lining, Naggie said: the start of a critical conversation about the “responsibility of understanding where data comes from and being confident that [researchers] can vouch for the quality of the data.”
The advent of big data comes with the risk of falsehood and imprecision. And the COVID-19 pandemic adds an element of urgency to expanding scientific knowledge of the virus, Naggie said, but that cannot come at the cost of research integrity.