We read the letter from Dr Maloney with great interest and wholeheartedly agree that the off-label use of drugs and devices is appropriate in routine clinical practice. If he assumed that we held a different position, then he is mistaken and perhaps we were unclear. In ophthalmology, off-label drugs and devices play an enormously important role in our ability to care for patients. We agree that clinical trials can sometimes point clinicians in the wrong direction, and that physicians have an ethical obligation to provide correct and appropriate care to their patients. This means they should be competent to assess the validity of clinical research and should not reflexively or thoughtlessly follow treatment protocols. The standards of evidence-based practice demand nothing less.
We agree—of course—that off-label use can be both ethical and appropriate when adopted in the routine care of patients, but our colleague has erred in his understanding of the consent process when applied to the off-label use of drugs, devices, and even surgical techniques, particularly when they deviate significantly from an accepted standard. In such cases, it would be a mistake not to discuss the off-label practice with the patient, and, we contend, it would be unethical not to include such language in the consent process. It is our view that patients generally care about Food and Drug Administration approval status, and it would be inappropriate for clinicians to decide for them whether the approval status of a drug and device should be disclosed. The beauty of informed consent is that more information, not less, is the key to shared decision making.
We are not merely considering a variation of surgical technique that is preferred by one surgeon over another, but, rather, the use of a drug or device that is approved for one indication yet is being considered and used for a very different indication. A robust consent process is uncontroversially required when patients are prematurely denied a proven and successful therapy like ranibizumab and changed to an unproven off-label drug that had never been injected into a human eye. Further, it is appropriate to question whether Theodossiadis and associates deviated from international standards by administering off-label Infliximab injections because they collected data in a prospective fashion that specifically requires oversight by the regulatory authorities in the United States and the European Union. Moreover, a robust consent process is obligatory when such unorthodox therapy is performed.
We encourage all our colleagues to analyze and question clinical trial outcomes as well as the on-label use of drugs and devices. Ophthalmology has a strong, proud, and vibrant tradition of practicing off-label. However, if we plan to deviate from routine clinical practice, even with good reason and adequate warrant, the anticipated off-label use of a drug or device must be disclosed.