Headlines: April 1st, 2009

Changes are needed in the way drugs are evaluated according to experts who say patients and health services are getting a poor return on their investment into new drugs. In an article published on bmj.com today they say the industry talks about the expense of bringing a new product to the market but it is the public who provide most of the support for developing and evaluating new drugs.

In their article Silvio Garattini, Director of Pharmacology at Institute for Pharmaceutical Research in Milan, and Iain Chalmers call for major changes in the evaluation of drugs to ensure that patients and health services benefit fully from new medicines. They accept that in countries where drug manufacturers represent an important contribution to the economy, there is an inevitable tension for governments trying to balance the interests of patients and services against those of the pharmaceutical industry.

They suggest four ways in which governments could alter the balance of support in favour of patients and health services but still benefit the industry. First, they suggest involving patients in shaping the therapeutic research agenda. This, they say, is a big challenge, but the necessary changes are unlikely to happen unless there is greater public awareness of the problems and more active engagement of patients and carers in the process. The authors also suggest a legal requirement for transparency in drug evaluation and a move to funding independent drug evaluations, as happens in Italy.

Finally, they propose there should be a requirement to demonstrate added value for all new drugs, which would help to ensure patients and health services get better value from their investment.

In an accompanying commentary, Michael Tremblay, a specialist business advisor, says although the proposals are controversial, many of them would benefit patients but he warns against following the Italian approach to funding independent clinical trials.