BMP Update: How Will Yale Data Findings Alter Physician Use & How Should Surgeons Address Risks With Patients?

At the North American Spine Society 28th Annual Meeting in New Orleans earlier this month, several physicians presented on bone morphogenetic protein and managing risk when using the biologic, in light of the recent Yale Open Data Access Project findings. Presenters included Vikas Patel, MD, from the University of Colorado. Alpesh Patel, MD, chief of orthopedic spine surgery and director of the spine fellowship at Northwestern University Feinberg School of Medicine, and Scott Daffner, MD, associate professor of orthopedic surgery at West Virginia University in Morgantown.

Dr. Vikas Patel presented data from a survey of NASS physicians on how they currently use rhBMP-2 in their practice. Dr. Alpesh Patel talked about the YODA results and what they show. Dr. Daffner discussed addressing the use of BMP with patients and the steps to take to gain permission.

How are NASS surgeons using BMP?

NASS survey results showed the majority of physicians, 58 percent, are only mildly concerned about the cancer risk posed by use of BMP and 40 percent are mildly concerned with the risk of retrograde ejaculation. Only 3 to 5 percent of physicians surveyed are highly concerned with such complications.

Respondents also shared that the 41 percent have decreased their frequency and dose of BMP due to concerns raised in the last year while 30 percent have not changed their frequency of use or dose. The survey also revealed that the majority of surgeons use BMP for ALIF surgeries in conjunction with PEEK cages. 

What concerns did the YODA survey raise?

The Yale Open Data Access Project attempted to crate a new way of evaluating industry-funded projects. The YODA BMP study was funded by a $2.5 million grant from Medtronic and approached the information with an effort to separate all financial interests from clinical interests. Medtronic released all human data from its Infuse trials and two independent sites conducted data review. The device maker had no direct role.

The two analyses came to agreement on several points, most notably that BMP use showed no difference in outcomes compared to the iliac crest bone graft. They also agreed that BMP use in anterior cervical fusions posed a clear safety risk, while posing no significant risk for anterior and posterior lumbar fusions. BMP was credited with increasing leg and back pain in posterolateral lumbar fusions.

However, the two sites differed on their assessment of the cancer risk posed by BMP. They also concluded more research would be needed to determine a clear relationship between BMP and cancer.

The takeaway from the tests, Dr. Alpesh Patel says, is that BMP should be used sparingly as a last resort.

How should this impact patient care?

This new information about potential risks with BMP use, as well as the bad press generated from the controversy, leaves surgeons in a difficult position when BMP use is best for a patient, Dr. Daffner says. The YODA study has created a need for surgeons to justify the use to their patients and to obtain patient consent.

The American Academy of Orthopaedic Surgeons' guidelines for off-label BMP use states it is acceptable as long as the off-label use is in the patient's best interest and is based on sound medical evidence.

Dr. Daffner also recommends that surgeons talk to their patients prior to any BMP use and describe what the drug does, what its potential risks are and why the surgeon thinks it's the best option. Include alternative treatment options in case the patient does not give consent.

Describe everything in simple language and allow patients to ask questions; don't coerce them into consenting, he says.

He also recommends working with the hospital or practice's risk management department and drafting an informed consent document for patients to sign.

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