Days after Harvard Medical School said it found extensive falsified or fabricated data from the laboratory of a prominent heart researcher, doctors and scientists are urging a halt to a medical trial based in part on his work. They say that sick people should not be subjected to the risks of an experiment whose underlying science has been called into question.
…[Piero] Anversa is not directly involved in the heart failure trial, which is being run by a national clinical trial network supported by $63 million in federal funds. But given the turmoil and uncertainty over the work that helped lay the foundation of the trial, outside researchers called for a pause and careful examination of whether it should proceed. The trial carries inherent risks, because it requires an invasive biopsy that can cause serious complications.
One patient died after their heart was perforated during a biopsy.
“I think that the trial should be halted, and they should have an external review,” said Darryl Davis, a cardiologist at the University of Ottawa Heart Institute studying how to regenerate heart tissue. “The Anversa data comprised part of the rationale for that trial, and I think we have to understand better what these cells actually can do before we subject the patients to the risk of having an invasive procedure.”
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