The British Medical Journal has alleged that Novartis has been using some shady practices to hinder trials comparing Lucentis and Avastin for wet age-related macular degeneration.
For many years, cancer drug Avastin (Roche’s bevacizumab) has been used off-label in the US and UK to treat wet AMD, despite Novartis’s Lucentis (Roche’s ranibizumab) being licenced to treat the condition.
Why? Mainly because Avastin is around ten-times cheaper than Lucentis.
Novartis has argued that injecting Avastin into a patient’s eye presents a significant risk and that the techniques used to manufacture Lucentis plus the smaller sized molecule’s greater ability to penetrate the tissues of the eye make it much better suited to treat wet AMD.
However, the two drugs are chemically similar and, over the past three years, a number of UK and US government-funded trials have suggested that Avastin can be as efficacious and safe as Lucentis in treating wet AMD.
Using Avastin to treat AMD could save the NHS just over £100 million, argues the BMJ.
So why have things come to a head now?
Firstly, in 2012, Novartis tried to sue an NHS Trust to make it stop using Avastin off-label. It eventually dropped the lawsuit after the Trust agreed to use Lucentis instead (at a significantly reduced price).
Secondly, the BMJ has just published evidence from emails showing that doctors with ties to Novartis urged some primary care trusts to pull out of one trial. The BMJ said it has also learnt of attempts by Novartis to “derail” a second publicly funded UK trial.
The trial's chief investigator claimed that during the trial's planning stage, a Novartis representative tried to divert him to Novartis-funded work – making clear that the offer depended on him dropping the trial.
Even the charity, the Royal National Institute for Blind People (RNIB) became involved, backing the Novartis ethics argument. According to BBC news, the RNIB employee who raised the concerns now works for Novartis.
The General Medical Council (GMC) has made the legal position clear, reiterating that it is unlawful to prescribe an “unlicensed” medicine on the grounds of cost.
Interestingly, The World Health Organization has backed Avastin for ophthalmic use, adding the drug to its 'Essential Medicines' List.
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