FDA Investigates Death in Arthritis Study
The Food and Drug Administration (FDA) is investigating the death of a patient participating in a gene-therapy study for active inflammatory arthritis. Putting patient safety first, the FDA immediately placed the trail on clinical hold which means that treatment of patients in the study will be suspended and no new patients will be entered into the study. The FDA is working closely with the pharmaceutical company to determine the cause of the death .
The study involved injecting an altered virus into a joint affected by arthritis to inhibit the action of an inflammatory-causing molecules called tumor necrosis factor (TNF). Gene-therapy, while still in the investigational stages, is an important line of research that may allow more individual, targeted treatment options for people with severe arthritis.
“We offer our condolences to the family of the patient who died,” said Dr. John H. Klippel, president and CEO of the Arthritis Foundation. “It is important to carefully review the safety, risks and benefits of any new investigational arthritis treatment, and we applaud the FDA for their prompt action in informing the public of this occurrence and suspending the clinical trial while more is learned about the cause of this death. Gene therapy may hold great promise as a therapy for people with arthritis, but is still very much in the early phases of investigation."
For more information on this event, see the FDA's statement.
