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Main Article Content
Clinical, legal and ethical implications of the intra-ocular (off-label) use of bevacizumab (Avastin) – a South African perspective
Abstract
vessels develop in the choroids, causing leakage of fluid and
haemorrhage under the retina and leading to localised serous
detachment and loss of central vision. Vascular endothelial
growth factor (VEGF) stimulates growth of neovascular
membranes. Treatments have until recently yielded
disappointing results.
Ophthalmologists are using intra-ocular injections of
bevacizumab (Avastin), an anti-VEGF, to treat AMD. Avastin
appears to be safe and effective in the short term, but its intraocular
administration is entirely off-label. Avastin is registered
for treating metastatic colorectal and breast cancer.
The off-label use of medication is an important part
of mainstream, legitimate medical practice worldwide.
Lawyers representing plaintiffs injured by drugs increasingly
encounter off-label use claims. From a legal/ethical point
of view the off-label use of medication represents a delicate
balance between the statutory regulation of medication and a physician’s prerogative to prescribe medication that in his or her medical opinion will be beneficial to the patient. The main reason for the controversy created by the off-label use of Avastin is that there are anti-VEGF drugs on the market that have formal approval for the treatment of AMD (and other eye conditions). Lucentis, for example, is extremely expensive, with treatment cost approximately 50 times that of Avastin. Many patients suffering from AMD and macular oedema
cannot afford the registered product. The off-label use of Avastin has passed the innovative or experimental stages, as ophthalmologists have used it regularly and openly for a long time, with good success.
Such use therefore cannot be considered careless, imprudent or unprofessional. We submit that an ophthalmologist who omits to inform a patient of the availability of Avastin for this form of treatment may be found to be negligent. Protocols developed by the South African Vitreoretinal Society and endorsed by the Ophthalmological Society of
South Africa for administering Avastin and other intra-ocular medication intravitreally should be strictly adhered to.
