Drug research “innovation crisis” is a myth

The widely touted “innovation crisis” in pharmaceutical research is a myth, argue experts in an article published on bmj.com today.

They say the real crisis stems from current incentives that reward companies for developing large numbers of new drugs with few clinical advantages over existing ones.

Since the early 2000s, numerous articles and reports have claimed that the pipeline for new drugs will soon run dry, write Donald Light from the University of Medicine and Dentistry of New Jersey and Joel Lexchin from York University in Toronto. Yet data indicate that the number of new drugs licensed remains at the long term average range of 15-25 a year.

The authors argue that telling “innovation crisis” stories to politicians and the press “serves as a ploy to attract a range of government protections from free market competition.”

Furthermore, independent reviews have concluded that about 85-90% of all new drugs over the past 50 years have provided few benefits and considerable harms.

And, although the industry emphasises how much money it devotes to discovering new drugs, they say most research funds go towards developing scores of minor variations that produce a steady stream of profits. Heavy promotion of these drugs can account for up to 80% of a nation’s drug spending, they add.

They also warn that companies exaggerate research and development costs to lobby for more protection from free market competition. Yet, according to an independent analysis, the 1.3% of revenues devoted to discovering new molecules compares with an estimated 25% spent on promotion, giving a ratio of basic research to marketing of 1:19.

So, what can be done to change the business model of the pharmaceutical industry to focus on more cost effective, safer medicines, they ask?

The first step should be to stop approving so many new drugs of little therapeutic value. “EU countries are paying billions more than necessary for drugs that provide little health gain because prices are not being set to reward new drugs in proportion to their clinical value,” they say.

They also believe that regulators should be publicly funded “to end industry’s capture of its regulator” and that new ways of rewarding innovation should be considered. “This approach would save countries billions in healthcare costs and produce real gains for people’s health, they conclude.

A second article argues that drug manufacturers should have to show how their products compare to existing treatments before approval Jonathan Cylus from the London School of Economics and colleagues say that the benefits of requiring comparative evidence for new drugs outweigh the risks, and would help ensure that the best therapies reach patients.

Raising the evidence standards could also encourage manufacturers to concentrate on the development of new drugs in therapeutic areas with few or no alternatives, they add.

Source: BMJ