Wednesday, March 30, 2011


It's no secret that pharmaceutical companies spend a large amount of money on promotion and marketing of their products, but the amount going into research and development is not insignificant (2004 US estimate of over $24 billion in R&D expenditures). But how much of that R&D money translates into innovative new products or improvements on current therapeutics?

The French publication Prescrire (link to English site) provides an annual report on new drugs released in France and rates them based on therapeutic advance and risk-benefit balance. In 2010, they reviewed 97 new drugs and indications, but first the rating system:
Bravo: The product is a major therapeutic advance in an area where previously no treatment was available.

A Real Advance: The product is an important therapeutic innovation but has certain limitations.

Offers an Advantage: The product has some value but does not fundamentally change the present therapeutic practice.

Possibly Helpful: The product has minimal additional value, and should not change prescribing habits except in rare circumstances.

Nothing New: The product may be a new substance but is superfluous because it does not add to the clinical possibilties offered by previous products available. In most cases it concerns a me-too product.

Judgement Reserved: The editors postpone their rating until better data and a more thorough evaluation of the drug are available.

Not Acceptable: Product without evident benefit but with potential or real disadvantages.
The review includes new products (other than generics copies) and new indications proposed by drug companies as well as new dose strengths and new form/presentations of existing drugs. Results from the past 10 years can be found here including the 2010 data reproduced below:

In 2010, over half the new products or indications added nothing new to existing clinical possibilities and almost 20% had potential or real disadvantages over current practice. The lone real advance was imatinib (Gleevec) reassessed in inoperable or metastatic gastrointestinal stromal tumours.

While breakthrough drugs might be expected to be relatively rare (only 2 in the last 10 years by Prescrire's account), the fact that 70% of new drugs or indications - in France, at least - represented no change or a step backwards from currently available interventions is not very encouraging. Where's the innovation? Sales techniques, it seems.


Anonymous Coward said...

I had the sense it would be bad, but this is abysmal. Considering how much science gets done and how many clinical trials go on at any given time, there is clearly a bottleneck somewhere. I wonder if it's just a consequence of pharmas being risk adverse. Only incremental innovations based on already approved products get pushed through the system becasue those have guaranteed results and already defined target populations.

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