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Expert attacks decision in US to stop use of bevacizumab for eye condition

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d6169 (Published 26 September 2011) Cite this as: BMJ 2011;343:d6169
  1. Nigel Hawkes
  1. 1London

A decision by the US Department of Veterans Affairs to stop using the anticancer drug bevacizumab (marketed as Avastin) to treat wet age related macular degeneration after reports of infections apparently caused by contaminated syringes was criticised as unnecessary by a leading specialist in the eye disease.

Bevacizumab is unlicensed in the United States for treating age related macular degeneration but has been widely used because it is much cheaper and has the same mode of action as the licensed drug ranibizumab (Lucentis). At the end of August the US Food and Drug Administration reported a cluster of infections in the Miami area linked to a pharmacy in Hollywood, Florida, which had repackaged bevacizumab into syringes suitable for injection into the eye.

Patients from two Veterans Affairs hospitals—one in Nashville, Tennessee, and the other in the San Fernando valley, Los Angeles—are also reported to have become infected after injections of bevacizumab. Many lost their remaining sight; and the family of one man treated in Nashville has issued a claim for $4m (£2.6m; €3m) in damages for loss of sight and brain damage as a result of an infection.

But Philip Rosenfeld of the University of Miami told the New York Times that the recent incidents seemed to have stemmed from careless procedures by pharmacies and should not discourage the use of bevacizumab. “It took six years for something like this to happen,” he said, adding that there had been more than two million injections of the drug into the eye since the practice began in 2005 (www.nytimes.com/2011/08/31/health/31drug.html).

A study published in Retina in 2008 (28:1395-9, doi:10.1097/IAE.0b013e3181884fd2) by a team from Barnes Retina Institute in St Louis, Missouri, that compared the incidence of endophthalmitis, a dangerous infection, after 12 585 injections of bevacizumab and 14 320 of ranibizumab found that the incidence of infection was the same—three cases (0.02%)—in each group.

Defending its decision, a spokesman for the Department of Veterans Affairs said that it had stopped the use of injections of bevacizumab in the eye while an investigation was undertaken. “Once the investigation is complete, VA will assess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance,” the department said in a statement.

Meanwhile in Europe four organisations, one of which is supported by the drug industry, and the drug company Novartis, which markets ranibizumab outside the US, warned that the true extent of the problem was not known and that there were likely to be unreported cases, because when a drug is used for unlicensed indications there is no formal mechanism for reporting adverse events.

Jim Thomson, chairman of the European Alliance for Access to Safe Medicines, which coordinated the statement, said, “We strongly believe that unlicensed and off-label medicines should only be used when a licensed product is unavailable, and there should be a mandatory adverse reporting system in place.”

His statement was backed by the European Federation of Neurological Associations, the European Men’s Health Forum, and the European Depression Alliance.

The European Alliance for Access to Safe Medicines is supported by the drug industry and includes among its funding partners Novartis. The two directors of the alliance listed on the registry of companies in England and Wales at Companies House are Mr Thomson and Mary Baker, who is also president of the European Federation of Neurological Associations. Ian Banks, director of the European Men’s Health Forum, is also a member of the alliance’s board, and Mr Thomson is a former chief executive of the UK Depression Alliance.

Mr Thomson said, “Our position is clear and, I believe, clearly stated. It is certainly not the result of any undue influence exerted upon the EAASM [European Alliance for Access to Safe Medicines] or its board. Happily we are protected from that by our governing documents and structure.”

Novartis said it did not know any details of the statement, as the alliance determines its own work streams and projects.

In April the alliance published a report, When is a Medicine not a Medicine? (www.eaasm.eu/When_is_a_medicine_not_a_medicine/Report), which took the unlicensed use of bevacizumab as one of its three case studies. This was a departure for the organisation, which since its foundation in 2007 has focused mainly on counterfeit drugs. The report warned that reformulating the drug increased the risk of contamination.

Clinical trials have shown that bevacizumab and ranibizumab perform almost identically in preserving or improving vision. But ranibizumab costs around £750 a dose in the United Kingdom, against £50 for bevacizumab. A cluster of primary care trusts in southern England (Southampton, Hampshire, Isle of Wight, and Portsmouth) has calculated that switching from ranibizumab to bevacizumab would save it £4-5m a year.

The cluster’s board meets on 29 September to decide whether to implement such a policy. Its decision may provide an early test of whether the incidents in the US have affected sentiment in the UK.

Notes

Cite this as: BMJ 2011;343:d6169

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