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February 1, 2008

An Ethical View of the Ranibizumab and Bevacizumab Controversy—Reply

Arch Ophthalmol. 2008;126(2):286-287. doi:10.1001/archophthalmol.2007.51

In reply

We appreciate the concerns expressed by Packer and Jampol regarding the costs of drugs and their associated RCTs and that it may not be possible to conduct an RCT in all situations. We agree that cost plays an important role, but it should not be an excuse to not conduct an RCT, especially in prevalent blinding disorders such as age-related macular degeneration. An RCT does not always have to be sponsored by a company. A few select centers across the United States and the rest of the world can conduct investigator-initiated trials with funding from various state, federal, and even nongovernmental agencies. The National Eye Institute–sponsored trial comparing bevacizumab and ranibizumab1 as well as the Macular Telangiectasia Project natural history study2 are examples of multicenter studies where the funding is being provided by state, federal, or nongovernmental organizations and the costs are at least partially born by patient or subject third-party insurance carriers. The Diabetic Retinopathy Clinical Research Network3 has shown great leadership in this regard, and a similar network for age-related macular degeneration trials should be considered. For example, the issue of combination treatment for choroidal neovascularization associated with age-related macular degeneration is complex and, because by definition it involves multiple therapies, seems ideally suited to sponsorship by an investigator-led age-related macular degeneration clinical research network. We as physicians have the responsibility to provide our patients with the best possible evidence for a treatment, but we should not necessarily wait for a pharmaceutical company to come forward to conduct a clinical trial. While cost of drugs is an important consideration, physicians should first and foremost be concerned about evidence-based medicine. Safety and efficacy concerns must lead the therapeutic decision-making process. However, we acknowledge that cost may be an important factor to include in discussions with patients, particularly when there is a significant financial disparity between therapeutic options.

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