BMP Issue Not Going Away…Registries on the Rise…and More (Orthopedics This Week)
BMP Issue Not Going Away
A certain spine surgeon has been thinking a lot lately about the BMP controversy. He tells OTW, “It’s a real mess…the average orthopedic surgeon is at a loss as to whom to believe and whether or not BMP is safe. The surgeons who have been the principal investigators in the BMP studies—and who reported that even higher levels were safe—had significant conflicts of interest. True, there is no concrete evidence that the lower dose of BMP (4mg)—which is FDA approved—is associated with cancer. But when the dose was ramped up to 40 mg there did appear to be some association between BMP and cancer. A big issue is that the data was there but the original investigators who reported the results failed to include the data related to the cancer association. I still think that BMP is reasonably safe at a lower dose; but I would be very cautious about using it on a patient with a history of cancer. If someone has had a lump removed from a breast and the spine surgeon wants to use BMP…not a good idea.”
“The worst is that now we are stuck because you may get a better fusion with the higher dose. But then it’s like taking 20 aspirins instead of 3. Medtronic has contracted a new group of independent researchers from Yale to review and reanalyze the cancer data. I don’t think they will find anything dramatically different, but they might say that they don’t have enough data. And the question is, ‘Who will fund the study that would yield more answers?’”