Call & Times

Much-quoted study on COVID treatment retracted as bogus

- By MARILYNN MARCHIONE AP Chief Medical Writer

Several authors of a large study that raised safety concerns about malaria drugs for coronaviru­s patients have retracted the report, saying independen­t reviewers were not able to verify informatio­n that’s been widely questioned by other scientists.

Thursday’s retraction in the journal Lancet involved a May 22 report on hydroxychl­oroquine and chloroquin­e, drugs long used for preventing or treating malaria but whose safety and effectiven­ess for CO9ID-1 are unknown.

Its conclusion that the drugs were tied to a higher risk of death and heart problems in people hospitaliz­ed with CO9ID-1 led the World Health Organizati­on to temporaril­y stop use of hydroxychl­oroquine in a study it is leading, and for French officials to stop allowing its use in hospitals there. Earlier this week, WHO said experts who reviewed safety informatio­n decided that its study could resume.

“Not only is there no benefit, but we saw a very consistent signal of harm,” study leader Dr. Mandeep Mehra of Brigham and Women’s Hospital in Boston told The Associated Press when the work was published.

Many media outlets used the now-retracted study to attack President Donald Trump, who had several times suggested the drug as a possible treatment

The Lancet study relied on a database from a Chicago company, Surgispher­e.

Dozens of scientists questioned irregulari­ties and improbable findings in the numbers, and the other authors besides Desai said earlier this week that an independen­t audit would be done. In the retraction notice, those authors say Surgispher­e would not give the reviewers the full data, citing confidenti­ality and client agreements.

“Based on this developmen­t, we can no longer vouch for the veracity of the

primary data sources” and must retract the report, they wrote.

“I no longer have confidence in the originatio­n and veracity of the data, nor the findings they have led to,” Mehra said in a separate statement Thursday.

The Lancet’s notice said

“there are many outstandin­g questions about Surgispher­e and the data that were allegedly included in this study,” and “institutio­nal reviews of Surgispher­e’s research collaborat­ions are urgently needed.”

Desai and Surgispher­e did not immediatel­y respond to request for comments sent to phone numbers and email address listed on the company’s materials.

All the authors of the study should have had access to the data, said Dr. Steve Nissen of the Cleveland Clinic.

“You really don’t know what a study showed unless you have the actual data,” Nissen said. “This is unfortunat­e. Clearly this is a very important topic and we need good answers.”

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