Research suggesting that the vast majority of the new drugs launched by pharmaceutical companies are only tweaked versions of old ones, with little – if any – improvement in therapeutic effect, cannot but be alarming. The good news, however, is that there is a solution, or at least the start of one, if regulators are prepared to be brave.
Drug companies have any number of explanations for the "innovation crisis" that is severely hampering the development of new drug treatments. After decades of intensive research and development, they say, many of the most obvious discoveries have been made; not only is finding different "agents" therefore becoming steadily more difficult, but there are, anyway, proven benefits to iterative progress. Meanwhile, ever more onerous regulations are pushing up developers' costs, putting a price tag of as much as £1bn on bringing a new product to the market. And with many early patents now running out, companies' incomes are simultaneously being squeezed.
All are claims with which some outside the industry quibble. As the research reported in this newspaper today points out, development costs may indeed have risen sharply in recent years, but revenues have shot up far faster and the majority of spending is absorbed by marketing budgets. Hardly a constructive state of affairs. But even if the drug companies' excuses are justified, it would make no difference. The need to change the market incentives to encourage entirely new – more effective – treatments remains.
One proposal is that drug makers be asked to demonstrate that their product works better than those already available, rather than simply better than a placebo. That would certainly be a start. It would also be useful for the prices paid by government buyers – the NHS being an obvious example – to be more closely tied to effectiveness rather than abstruse capital returns calculations.
Signs that watchdogs in both Europe and the US are looking at reforms are welcome. But with the pharmaceutical market barely fit for purpose, it is time to stop talking and start doing.Reuse content