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Surgeons Failed to Identify Dangerous Side Effects of INFUSE

When the makers of a drug or medical device pay doctors to provide research on the safety and efficacy of the treatment, can the results be trusted? In the case of Medtronic’s bone growth product, INFUSE, there is major controversy over the fact the drug and device maker paid researchers a substantial amount to identify risks and those risks were not reported. INFUSE has been linked to numerous side effects since its release, leading to claims that it is dangerous and that its use can cause harm. This comes in stark contrast to the 13 trials funded by Medtronic in which no negative side effects were reported.

INFUSE is a combination of a drug and a device used to deliver the drug. It places a protein in the spine to encourage bone growth to fuse parts of the spine back together and make it more stable. It has been used to treat serious spinal injuries, as well as conditions as less serious conditions involving back pain. While the treatment is effective for some, it has been linked to infection, further pain, cancer, the formation of cysts and retrograde ejaculation in men. Not one of those side effects was reported by the physicians paid by Medtronic to provide early research.

The pre-market research relating to INFUSE is at the heart of the issue. The information Medtronic provided to the Food and Drug Administration (FDA) included side effects identified by its paid researchers. Once the drug was approved, it now appears physicians began using INFUSE for patients who only stood a small chance to benefit from the treatment, believing that no harm will occur if it does not work. In that circumstance patients who would almost certainly have recovered eventually with no treatment are exposed to undisclosed side effects by doctors who could not have known about the consequences and actual risks of the product.

Medical professionals are responsible for knowing the side effects of the drugs and devices they order and for informing their patients of those risks. The manufacturer must communicate those risks after real-world objective studies intended to uncover all potential side effects. That process appears to have broken down here.

Source: Forbes, “Medical Journal Slams Medtronic Over Payments To Doctors,” Matthew Herper, June 28 2011