The generation gap

Flicking through the pages of Manufacturing Chemist, the reader could be forgiven for thinking that the stream of new drugs coming onto the market is boundless. But scratch the surface a little and some disquieting trends start to emerge. Far from disgorging an endless progression of ever more efficient therapeutic compounds, most big pharma pipelines are significantly less full than they were 10, five or even three years ago.

There is no denying that developing new drugs is an expensive and risky business - and becoming more costly and chancier all the time. But without r&d, where is the next generation of medicines to come from?

With few desirable merger or acquisition targets left, the need to share the cost and the risk is reflected in the plethora of in-licensing, out-licensing and joint venture projects that also occupy a prominent place in this magazine. Much of the pressure on big pharma comes from shareholders and institutional investors constantly seeking rapid returns and short-term gains. But drug discovery and development is a long-term process, and reducing the time to market cannot be done at the expense of patient safety and therapeutic efficacy.

So perhaps manufacturers can be forgiven for seeming to concentrate much of their attention on medical conditions that mainly afflict the populations of the affluent, developed economies - hypertension, obesity, coronary heart diseases, COPD, type II diabetes, and lung, breast and colon cancer. Meanwhile diseases that affect mainly underdeveloped countries, such as river blindness, malaria and cholera, are sadly neglected despite the best efforts of the WHO. When all's said and done, drug manufacturers are not philanthropic organisations, and commercial pressures are bound to make them focus on the more lucrative prospects.

Just as much a matter for concern is the tendency for some companies to take the easier and cheaper route of extending the patent life of their products by reformulating them for a different delivery method or submitting supplementary NDAs for them. Intellectual property is a valuable asset and should be defended, but perhaps if some of the resources that go into fighting legal battles over patents were redirected into r&d, pipelines might look a little healthier.

It is true that some individual governments and other bodies do offer incentives to encourage r&d, and notably the development of so-called orphan drugs, but these are just a drop in the ocean.

With so many conflicting interests pulling the pharma industry in different directions, the lowest hanging fruit will remain the greatest temptation, and one that it would be unrealistic to expect manufacturers to resist.