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Two Drugs, One Possible Issue


The US Food and Drug Administration rejected Medtronic's bone-growth product Amplify back in March, due to cancer risk concerns. Amplify is a higher-dose version of the company's Infuse product. At a conference this week, Stanford University's Eugene Carragee said that not all of Medtronic's clinical trial data had been made public before, and that data "showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion," The New York Times reports. Carragee added that the Amplify results may also be of importance for Infuse, as the products have the same active ingredient and as some doctors prescribe Infuse at high doses, closer to those seen in Amplify.

In August, Medtronic awarded Yale University $2.5 million to review Infuse study data. That review is expected to be finished next year, and a spokesperson tells the Times that that review "will address the safety and effectiveness" of Infuse.

The Scan

Study Links Genetic Risk for ADHD With Alzheimer's Disease

A higher polygenic risk score for attention-deficit/hyperactivity disorder is also linked to cognitive decline and Alzheimer's disease, a new study in Molecular Psychiatry finds.

Study Offers Insights Into Role of Structural Variants in Cancer

A new study in Nature using cell lines shows that structural variants can enable oncogene activation.

Computer Model Uses Genetics, Health Data to Predict Mental Disorders

A new model in JAMA Psychiatry finds combining genetic and health record data can predict a mental disorder diagnosis before one is made clinically.

Study Tracks Off-Target Gene Edits Linked to Epigenetic Features

Using machine learning, researchers characterize in BMC Genomics the potential off-target effects of 19 computed or experimentally determined epigenetic features during CRISPR-Cas9 editing.