By Daniel L. Freidlin
Wednesday, January 16, 2019
In recent years, bone growth agents have been increasingly used as substitutes for iliac crest bone autograft during spinal fusion. This bone growth agent, known as bone morphogenetic protein (BMP), is a naturally occurring human protein that stimulates bone formation. During fusion surgery, the spinal surgeon may place BMP on a sponge at the surgical site to facilitate adjacent bones to fuse together. Proponents of BMP suggest it is beneficial over the use of traditional iliac crest bone autograft in that it is less painful and associated with shorter recovery times. Different forms of BMP have been discovered and each form serves a different function. For example, BMP-2 induces bone and cartilage formation by playing a role in osteoblast differentiation.
INFUSE (BMP-2) has been tested and FDA approved for anterior lumbar interbody fusion (ALIF). However, INFUSE has also been used “off-label” in other operations. One study concluded that as of 2010, 85 percent of procedures using BMP were for off-label use. For example, INFUSE has been used off-label to promote bone growth during cervical fusion. Although off-label use of drugs and products is prevalent in clinical practice, the question arises as to whether the patient needs to be informed that the product is being used for a purpose that is not approved by the FDA.
Off-label use of a product refers to the practice of using it for a purpose that has not been formally approved by the FDA. Once a product is approved for a particular use by the FDA, physicians may use it off-label or for other purposes. In fact, it is a given that the medical community’s clinical experience with the potential benefits of a product will most often move faster than the FDA approval process. Congress amended the Food, Drug and Cosmetic Act (the law that gives power to the FDA) to state that the law will not limit the ability of a healthcare provider to prescribe an approved drug for “any condition or disease.”
To answer the question of whether a patient needs to be specifically told that the medication is being used off-label, it is helpful to consider what FDA approval really means. The FDA regulates the marketing of drugs and devices, not the practice of medicine. Some products never obtain FDA approval for a legitimate indication because the cost of conducting the clinical trials needed to obtain the approval outweighs the benefits. Given that a lack of FDA approval for a particular indication does not mean that the drug is not safe, there has been no legal requirement imposed on the clinician to specifically inform the patient that a drug is being used off-label, so long as its use is not considered human experimentation or research. If the off-label use is not experimental, general rules of informed consent should apply. While the specific definition of informed consent varies by state — and exceptions apply —the physician is generally required to inform the patient of the risks, benefits and alternatives of treatment so the patient can make the decision as to whether to proceed. The amount of information that needs to be provided is a medical judgment that depends upon the specific treatment, associated risks, benefit to the patient and other variables. In other words, it is not black and white. As the off-label use of BMP has been the subject of controversy and litigation, surgeons may be wise to incorporate this into the preoperative risk and benefit discussion with the patient. As always, the informed consent discussion should be documented.