jueves, 7 de mayo de 2015
Novartis “embarked on a campaign to undermine and divert attention” from a cheap drug for vision loss to maintain the dominance of its more expensive treatment, an investigation alleges.
The Swiss firm, which markets Lucentis (ranibizumab) in Europe, blocked researchers’ efforts to conduct publically-funded trials of Avastin (bevacizumab) and lobbied the General Medical Council against allowing the off-licence use of the drug, the BMJ says.
Systematic reviews suggest Avastin – a cancer treatment – has comparable effectiveness to Lucentis as a treatment for wet age-related macular degeneration (AMD), a leading cause of vision loss and blindness in older people in the UK.
Avastin costs around £34 per dose compared to the £742 per dose cost of Lucentis, and research suggests using Avastin as an off-licence treatment for wet AMD could save the NHS £102 million a year. NHS figures show hospitals in England spent £244 million on Lucentis in 2012-13, a 21% rise on the year before.
Previous versions of GMC guidance “contained a clause that encouraged doctors to prescribe off-label for reasons of cost” – but the BMJ claims the medical regulator performed a ‘major U-turn’ after being lobbied by the ABPI, the MHRA and the Royal National Institute for the Blind, who count Novartis as a regular donor.
The investigation found the charity’s former policy and campaigns manager – who is now head of external affairs for oncology at Novartis – complained to the Health Research Authority challenging the ethics of a head-to-head study comparing Avastin and Lucentis.
Independent study investigators told the journal Novartis refused to supply Lucentis for use in the trials, and that company representatives “lobbied potential principal investigators against the trial, telling them that the protocol was seriously flawed”.
In a statement Novartis says it is “committed to high standards of ethical business conduct”. A spockesperson adds “We take any allegations seriously and are closely reviewing the content of the article. Novartis does not tolerate unethical behaviour by its associates in any country. We strongly believe that patients have the right to the highest standard of care and that this right should be defended to promote safety and quality as the key drivers of health policy.” (Más)