Wednesday, January 31, 2007

Roche - Herceptin: how much and for how long?

The drugs industry would not fund trials which could reduce the period over which their products have to be used, Cancer Research UK claimed on the BBC this week.

The claim was made by the charity's director of clinical trials, Kate Law, during an appearance on Radio 4's Woman's Hour which also featured Barbara Clark, the patient who led the recent high-profile campaign to make Roche's breast cancer drug Herceptin (trastuzumab) available on the NHS.

Addressing the regulation of new drugs and their availability on the NHS, Ms Law said it was right that new products are thoroughly tested for efficacy, safety and cost-effectiveness. But she added: "Currently we give Herceptin for a year and there is no good evidence why it should be given for a year. It is what the drug company decided upfront. We are now doing trials in the UK that are following some done in Finland that look as though nine to ten weeks would be sufficient."

She continued: "Wouldn't that be great if it was an equivalent outcome? We are not going to get the drug companies doing that sort of trial. That is why research organisations like Cancer Research UK are vital to move the evidence forward."

On the programme Ms Clark rejected suggestions she was used by Roche as part of the company's PR campaign to have Herceptin made available on the NHS.

"That would be against the law. What they did was give me the hard research data so I could go on radio and TV and not get my facts wrong," she said.

A spokesman for Roche said that the recommendation that the drug be used for a year was based on clinical trials involving 12,000 people compared to around 130 involved in the Finnish research.

He insisted that the company would fund research which could see the recommended period of use reduced, pointing to an on-going study into halving the period of use for its hepatitis C drug Pegasys (peginterferon alfa-2a).

By Chris Mahony.
Source: PharmaTimes

Insider's view: Great news! When will the trials be starting?

No comments: