Novartis Pauses Trials of Experimental Therapy After Three Deaths

The experimental treatment, known as rap-cel, is a so-called CAR T-cell therapy that was being investigated in these trials for autoimmune and neurological disorders. Novartis says it is conducting a comprehensive review of the three deaths and working with independent safety boards to determine what happened.

CAR T therapies involve collecting a patient’s immune cells, genetically modifying them in a laboratory, and returning them to the body with the aim of attacking specific targets. Originally developed primarily as cancer treatments, the technology is now being investigated for autoimmune diseases. Drug firm Bristol Myers Squibb has also voluntarily paused trials of a rival CAR T therapy, zola-cel, while it too reviews safety data. Both treatments remain experimental.

These developments provide another reminder that sophisticated new medical technologies can carry serious and sometimes unforeseen risks. While pharmaceutical innovation is frequently portrayed as an almost inevitable march towards safer and more effective treatments, the biological consequences of manipulating the human immune system can be extremely complex. Patients deserve full transparency about serious adverse events occurring during clinical trials, while regulators must ensure that commercial pressure to develop lucrative new treatments does not take precedence over patient safety.

To learn how the pharma industry deliberately uses bribery and other corrupt practices to increase drug sales, influence prescribing, and secure favorable treatment from governments and regulators, see this article on our website.