The medical journal that published the pivotal clinical trial used to approve the drug Tavneos for a rare autoimmune disease has formally retracted that study — and federal regulators have proposed withdrawing the drug's approval entirely.
The New England Journal of Medicine retracted the 2021 paper detailing the pivotal ADVOCATE clinical trial, citing concerns that patient outcome data were altered and that some researchers had been unblinded during the trial. The retraction was requested by two of the trial's academic authors after an FDA investigation found that results for nine patients had been changed. According to the retraction note, the primary endpoint assessments for nine patients were readjudicated after database lock and trial unblinding, without the knowledge of the two requesting authors — and this was not disclosed in the published article.
