Innovative Medicines: 24 years from lab to market?

How long does it take to get a new medicine out of the lab and into the doctor’s office? In Brussels, the answer to that question comes with a 2 billion euro price tag.

A study, published in Science magazine September 5, sheds some new light on this very old problem in healthcare: how to speed up translational research – getting potential new medicines moving faster to the clinic. Conventional wisdom, often quoted by drug-industry executives, suggests it takes 10 to 13 years and €800 million to get a new chemical entity to market. And one in 10,000 candidates actually makes it.

But the new analysis, by a group of mostly Greek researchers from the University of Ioannina, tried to put some rigorous methodology behind this kind of calculation. It looked only at blockbuster treatments – those whose research papers hit the top-citation rankings with at least 1,000 references between 1990 and 2004. That yielded 32 treatments for their study, including tamoxifen (breast cancer), statins (anti-cholesterol) and zidovudine (AIDS.)

What they found was that, on average, it took 24 years to get from the first description of the chemical in a research paper or patent to the publication of the top-cited article – usually, reporting on a successful randomized trial. Not surprisingly, controversial treatments took longer than well-proven ones. Specifically, those treatments whose effectiveness was later contested – post-menopausal hormone replacement therapy, for instance – were shown, on looking back over the record, to have taken an average 44 years to get from first description to (ultimately refuted) top-cited paper – more than twice as long as the really successful new medicines.

Cue a debate that has been going on in Brussels, as in other capitals: How to get more new, and more effective, drugs moving into the healthcare system? As it is, the pace of new drug launches has slowed dramatically over the past decade. At the same time, the average time required to get new drugs to market – however you measure it – has been growing longer.

Late last year, the European Union put a €2 billion marker down to try to solve this problem. Called the Innovative Medicines Initiative, it’s a public-private research programme – half funded by the EU, and half by the drug companies that participate in it.

The aim of IMI reads like it could have been lifted from the Science report: To speed up early-stage drug-development, or translational medicine. IMI research projects, says one report for the Commission, “address the bottlenecks in the conventional drug discovery and development process as well as relevant regulatory considerations.” They do so by coordinating funding for cutting-edge research projects on tools and methods to help predict drug-safety problems earlier, use biomarkers to predict drug-efficacy sooner, and improve knowledge-management and education in the drug-development process. All goals that, if achieved, could shorten the 24-year lag cited in the Science report. The programme managers are this month reviewing the first crop of 150 research proposals.

Programmes in Brussels get created for all kinds of strange reasons. And IMI has its own set of conceptual problems; the early Commission rhetoric often made IMI sound in part like an industrial-support programme for European Big Pharma (a laughable notion, given the wealth and power of Europe’s drug giants.) That there’s also a clear policy reason for a programme like this – and a reason that independent research like the Science report confirms – is a pleasant surprise. It will be even nicer if IMI actually helps solve the problem for which it was created.