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Concerns About Off-Label Bone Growth Treatment in Kids

No Longer Accepting Cases

October 15, 2012 — Researchers are warning against using bone-growth products in children until more research is conducted, according to a new study published in the October issue of the Journal of the American Medical Association.

Although about 9.2% of spinal surgeries in children use Bone Morphogenic Proteins (BMP), the products are not approved by the U.S. Food and Drug Administration (FDA) in children. Furthermore, the products have never been evaluated in clinical studies for safety or effectiveness in children.

Medtronic Inc. markets the bone-growth products. The InFuse is the most popular of these products. It was first approved by the FDA in 2002, but only for limited use in adults who needed extra bone growth after spinal surgery. Since its approval, the use of InFuse and other BMP products during spinal surgery has expanded greatly. Sales of these products generate hundreds of millions of dollars per year, mostly “off-label.”

Despite the growing “off-label” use of the InFuse in children, Medtronic has never studied BMP products in children. The researchers were concerned that the benefits, safety, and effectiveness of these products are not fully known. BMP consists of a genetically-engineered bone growth product, which could interact with normal growth proteins in growing children.

According to Dr. Emily Dodwell, the lead researcher on the study, surgeons should stop using BMP in children “until it has been shown to be safe and beneficial.”

Researchers have already linked the InFuse to many serious side effects in adults. Side effects include excessive bone growth, inappropriate bone formation, male infertility, and more.

Medtronic has also been accused of making payments to doctors to produce research that was favorable to the InFuse, and then failing to disclose financial ties. In 2011, the U.S. Senate Finance Committee investigated payments of $12 million and $16 million to researchers who conducted 13 clinical studies that found no serious side effects associated with the InFuse. When the studies were published, the researchers did not disclose that they received money from Medtronic.

Then, independent researchers published a report in The Spine Journal that linked the InFuse to high rates of infection, cyst formation, pain, and cancer. Other studies have linked the InFuse to male infertility and other side effects.

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