Concerns About Off-Label Bone Growth Treatment in Kids

October 15, 2012 — According to a study published in the Journal of the American Medical Association, 9.2% of spinal fusion surgeries in children used Bone Morphogenic Proteins (BMPs) — a genetically engineered bone-growth product that has only been approved by the U.S. Food and Drug Administration (FDA) for limited use in adults who are not healing very well after spinal surgery. The FDA has not approved the use of BMPs in children.

BMP products are marketed by Medtronic, Inc. The most popular product is the Medtronic InFuse, which was approved in 2002. The InFuse has generated sales of hundreds of millions of dollars per year, with much of the use “off-label” (not approved by the FDA).

Medtronic has not performed clinical trials of BMP in children. The researchers found that in 2009, 771 of 8,289 spinal surgeries in children used BMP. The researchers were concerned that because BMP has never been studied in children, no one really knows the risks or benefits of using the product.

Dr. Emily Dodwell, of the Hospital for Special Surgery in New York and author of the study, said that surgeons should stop using BMP in children “until it has been shown to be safe and beneficial.”

The InFuse and other BMPs products have been linked to many severe side effects in adults, including excessive bone growth, bone formation in unintended locations, male infertility, and more.

In 2011, Medtronic faced investigations from the U.S. Senate Finance Committee due to large payments the company made to doctors who produced favorable research. In 13 clinical trials of the InFuse sponsored by Medtronic, no side effects were reported. However, a report in The Spine Journal found that as many as half of patients treated with the InFuse had infections, pain, cyst formation, or cancer. The report also found that the studies may have been designed in a way to make the InFuse look good. Researchers also failed to disclose that they received significant financial support from Medtronic, between $12 million and $16 million.