Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness

Mr. Seife also wrote in his 2015 paper that “there is no formal requirement for authors seeking to publish clinical trial data to disclose any adverse findings noted during FDA inspections. Journals should require that any such findings be disclosed.”

But it’s not clear that disclosing the information to the medical journals would solve the problem.

Four years after his paper named a host of potentially flawed papers, such as the ones that resulted from the ARISTOTLE study, Mr. Seife says he was unaware of any cases where the journals that published those studies have retracted them or alerted their readers to a potential problem.

Reference

1. Garmendia CA, Nassar Gorra L, Rodriguez AL, et al. Evaluation of the inclusion of studies identified by the FDA as having falsified data in the results of meta-analyses: The example of the apixaban trials. JAMA Intern Med. 2019 Mar 4. [Epub ahead of print]