Feature Drug Regulation

Attacks on publicly funded trials: what happens when industry does not want to know the answer

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1701 (Published 01 April 2015) Cite this as: BMJ 2015;350:h1701
  1. Deborah Cohen, investigations editor, The BMJ
  1. dcohen{at}bmj.com

In the second part of The BMJ investigation into struggles to use intravitreal bevacizumab, Deborah Cohen reveals the challenges facing those conducting publicly funded clinical trials

As Britain’s doctors and commissioners call for bevacizumab to be used within the NHS to reduce the cost of treating wet age related macular degeneration, an investigation by The BMJ reveals how the drug industry hindered publicly funded trials comparing it with ranibizumab. The investigation shows how difficult it can be to achieve independent evaluation of drugs when industry’s business interests conflict with public health.

Bevacizumab and ranibizumab are monoclonal antibodies developed by biotechnology company Genentech: bevacizumab for intravenous use in cancer, ranibizumab for intravitreal treatment of eye disease. Roche subsequently acquired Genentech and has the intellectual property rights to both drugs, although Novartis has the rights to market ranibizumab in Europe. Roche has so far declined to apply for a licence for bevacizumab to be used in eye disease.

Philip Rosenfeld, professor of ophthalmology at the Bascom Palmer Eye Institute in Florida, was involved in the early trials of ranibizumab and pioneered the use of bevacizumab. He maintains that, although owned by the same company, bevacizumab was seen as an economic threat to the ranibizumab franchise.

Genentech had always encouraged its researchers to publish all their data. Rosenfeld said, “It was obvious from their published data that both drugs were derived from the same molecule that acts by inhibiting vascular endothelial growth factor (VEGF), preventing blood vessel growth.” He proposed a clinical trial of bevacizumab in patients with wet AMD, but he says Genentech wasn’t interested. So in 2004, with the help of his institution, Rosenfeld raised funds and ran a clinical trial himself.

The results were remarkable and immediate, he says, explaining how patients’ vision improved. He and the director of his …

View Full Text

Sign in

Log in through your institution

Free trial

Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial

Subscribe