Novartis AG Accused of "Bullying" Doctors to Drop Trial of Cheaper Drugs
April 2, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LONDON -- The British Medical Journal has leveled charges against Novartis AG , accusing the drugmaker of scuttling clinical trials of a cheaper alternative to Lucentis, a treatment for wet age-related macular degeneration (AMD) Novartis’ markets in Europe.
The Journal said Swiss-based Novartis has attempted to prevent medical officials from participating in trials of Avastin, a cheaper alternative to Lucentis. Avastin is currently used to treat cancer, including some brain tumors, but early clinical trials have shown that Avastin is also an effective treatment for AMD, although the medication has not been approved for that type of treatment.
According to British news reports, the BMJ said drug companies attempted to “undermine and divert attention” from the results of trials showing Avastin was just as effective as Lucentis. The magazine said emails obtained under a Freedom of Information request show clinicians with ties to Novartis had urged some primary care trusts to pull out of one trial.
Additionally, the BMJ accused Novartis of attempting to undermine a second publicly funded trial. The BMJ said the trial's chief investigator, Alex Foss, a consultant ophthalmologist at Queen's Medical Centre, informed the BMJ that a Novartis representative tried to divert him to Novartis funded work, with the prospect of future funds for personal research projects.
“Doctors and academics have carried out clinical trials despite threats and intimidation -and doctors leaders should follow suit and not allow themselves to be bullied either,” Fiona Godlee, editor-in-chief of the BMJ said in a press release. “Patients have volunteered to participate in clinical trials thinking that their contribution might save the NHS millions of pounds. It is unethical not to act on their altruism.”
Avastin sells for $74 to $96 per dose, while Lucentis sells for about $1,095 per dose. Some doctors in the United Kingdom have been prescribing Avastin for AMD treatment primarily due to the cost savings, although the nation’s General Medical Council reminded doctors it is unlawful to prescribe unlicensed medicines. The cheaper alternative to Lucentis could save Britain’s National Health Service $151 million annually.
Both drugs are owned by the same company, Roche , but Lucentis is marketed by Novartis in the United Kingdom, the BBC reported this morning. The British Medical Journal claims it has evidence that clinicians with ties to Novartis urged some primary care trusts to pull out of one trial, and alleges the company tried to derail a second U.K. trial, the BBC said.
Roche has never funded trials of Avastin for use as an AMD treatment, but publicly funded trials have shown its effectiveness is comparable to that of Lucentis, the Independent reported. An analysis by the Cochrane group found no difference in serious side-effects between the two drugs.
A Novartis spokesperson denied the charges.
“Novartis is committed to high standards of ethical business conduct. Novartis does not tolerate unethical behavior by its associates in any country, and has a comprehensive compliance program in place to help ensure that our associates comply with the company’s code of conduct and all applicable laws,” told the Independent.
Wet macular degeneration causes vision loss in the center of one’s field of vision. Wet macular degeneration is generally caused by abnormal blood vessels that leak fluid or blood into the region of the macula, according to the Mayo Clinic. Macular degeneration, both wet and dry, impact between 30 and 50 million people globally.