Earlier this year, a raging controversy regarding a new drug spilled into the pages of a leading medical journal: the head of the U.S. Food and Drug Administration and another official publicly called for the retraction or correction of a peer-reviewed article about the drug. They didn’t get their wish. Now, documents released by the FDA via a lawsuit shed light on the attempt — and show how tricky it can be to correct the official record.
The controversy surrounds the approval of eteplirsen, a drug approved last September to treat Duchenne Muscular Dystrophy, a rare but invariably fatal disease that strikes (mostly) young boys. Eteplirsen was approved over the objections of the FDA team that reviewed the drug, which determined that there was insufficient evidence to approve the drug.
But the controversy didn’t end within the walls of the FDA complex. Ellis Unger, who led the review team, believed that one of the principal studies of the drug, published in the Annals of Neurology, was “misleading” because it was based on “unreliable data.” So in early November, Unger, joined by the then-head of the FDA, Robert Califf, took the extremely rare move of writing to the editor of the journal to “urge that the paper be corrected or retracted….”
According to the documents, the authors of the Annals article did, in fact, agree to correct the article.
On November 9, 2016, Clifford Saper, Annals‘ editor in chief, wrote to Califf and Unger:
Continue reading Released FDA docs reveal details of agency’s (failed) attempt to retract paper
The head of the U.S. Food and Drug Administration (FDA) has called for the retraction of a study about a drug that the agency itself approved earlier this week, despite senior staff opposing the approval.
On September 19, the FDA okayed eteplirsen to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder that results in muscle degeneration and premature death. Several of its top officials disagreed with the drug’s approval, questioning how beneficial it will be for patients, as Forbes, MedPage Today and others reported.
In a lengthy report Commissioner Robert Califf sent to senior FDA officials on September 16 — that was made public on September 19 — he called for the retraction of a 2013 study published in Annals of Neurology funded by the seller of eteplirsen, which showed beneficial effects of the drug in DMD patients. Califf writes in the report:
Continue reading Amid controversial Sarepta approval decision, FDA head calls for key study retraction
Neuroscientists have retracted a research letter less than two months after it appeared, admitting they appeared to pass off others’ data as their own.
Two of the researchers are listed as affiliated with the University of California, San Francisco (UCSF), and the incident has led to a misconduct investigation at the institution, a UCSF spokesperson told us.
The article, “DNAJC6 variants in Parkinson’s disease and amyotrophic lateral sclerosis,” appeared in April. It was quickly followed by this notice, dated in May: Continue reading Neuro journal pulls article for data theft, prompts misconduct probe