Patients and health services are getting a poor return on their investment into new drugs, say experts in an article published on bmj today. Industry makes much of the expense of bringing a new drug to market, yet the public provides most of the support for developing and evaluating new drugs, write Silvio Garattini and Iain Chalmers.

They call for major changes in the way that drugs are evaluated to ensure that patients and health services benefit fully from new medicines.

In countries where drug manufacturers are major contributors to the national economy, an inevitable tension confronts all governments that try to balance the interests of patients and health services against the interests of industry, explain the authors.

So they suggest four ways in which governments could alter the balance of their support in favour of patients and health services while also benefiting the industry.

First is to involve patients in shaping the therapeutic research agenda. This presents a considerable challenge, but the changes that are needed are unlikely to occur unless there is much greater public awareness of the problems and active engagement of patients and carers in the process, say the authors.

They also suggest making transparency in drug evaluation a legal requirement. Although industry has voluntarily taken some important steps towards greater transparency, mandatory, prospective publication of trial protocols should now be required by law, they write.

There should also be a move to fund independent drug evaluations, as currently happens in Italy.

Finally, there should be a requirement to demonstrate added value for all new drugs. This, say the authors, will help to ensure that patients and health services receive better value for their investment.

"We believe that, if informed and consulted, the public would support the changes we have proposed," write the authors. "It remains to be seen how far governments are prepared to go in promoting changes designed to serve the interests of patients and health services more effectively, and how far the drug industry is prepared to go in acknowledging that its current ways of working are not as effective as they might be, scientifically or financially," they conclude.

Although controversial, many of these proposals would benefit patients, writes Michael Tremblay, a specialist business advisor, in an accompanying commentary. However, he warns against following the Italian approach to funding independent clinical trials.

"If you want to build a strong medicines research community that is more likely to act in the wider public interest, copying Italy may not be a good idea," he concludes.

"Analysis: Patients and the public deserve big changes in evaluation of drugs."
BMJ online

"Commentary: Dangers of doing as the Romans do."
BMJ online

Source
British Medical Journal