A law firm has informed the US Food and Drug Administration that a regulatory filing from a company developing an Alzheimer's disease treatment may include data showing signs of manipulation, Retraction Watch reports.
The firm, Labaton Sucharow, which Retraction Watch notes is known for filing shareholder suits, submitted a citizen's petition to the FDA regarding Cassava Sciences' simulfilam. In the petition, the firm says its clients have "grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy." In particular, the petition notes anomalies with western blot images in publications from City University of New York's Hoau-Yan Wang and Cassava's Lindsay Burns supporting the filing as well as the methodology used in post-mortem brain analyses, and more.
In a statement, Cassava says the claims are "false and misleading."
Retraction Watch notes that commenters on PubPeer have now raised concerns regarding other studies from Wang and Burns. In addition, Labaton Sucharow recommends that FDA audit the supporting work and pause ongoing simulfilam trials, it adds.