Thursday, 21 February 2013

Something isn't right in the world of pharmaceuticals. Alarm bells are ringng.

Something is not right in the world of pharmaceuticals. But it isn't reflected in the number of new drugs coming to market.

The widely held belief that the UK supply of innovative new medicines has conspicuously dwindled in recent decades, is not borne out by the evidence, or at least this is what is suggested by research published in the online journal BMJ Open.

The prevailing view is that pharmaceutical industry innovation has been in decline, with fewer new drugs launched in recent decades than before—despite more cash being pumped into research and development—prompting a good deal of hand-wringing, say the authors.

They tested whether this view was justified, by looking at all new medicines added every year to the prescribing and dispensing drugs bible, the British National Formulary, or BNF for short, over 30 years. The BNF is updated every six months.

In terms of the drugs industry, the UK punches above its weight. After the US, the UK is the second largest source of new drug development, generating more than 10% of all new medicines around the globe.

All new synthetic chemical entities and new biological drugs, such as vaccines, blood products, and gene therapies were included, based on their first appearance in the BNF between 1982 and 2011.

New products covered modifications of existing drugs as well as radical breakthrough treatments. Different doses and formulations containing the same active ingredients were only counted once, and generic versions of brand drugs were excluded.

The researchers found no significant linear trend pointing to a decline in the number of new drugs introduced into the UK over that period, which averaged just under 24 a year.

But the authors did find a pattern of peaks and troughs, with dips invariably followed by a surge in new arrivals. New drugs, in seems, come in waves.

After a dip in the mid-1980s, with around a dozen new drugs coming on to the market between 1985 and 1987, new arrivals increased every year, peaking at 34 in 1997.

This peak was again followed by a dip, with around 20 new drugs a year between 2003 and 2006, followed by a further peak in 2010.

And extending the timeline back to the 1970s indicated an overall slight but significant increase of 0.16 new drugs every year between 1971 and 2011, “contradicting the widely held view that the number of new medicines being launched is declining,” say the authors.

They conclude that the perceived “innovation dip” is a product of the time periods studied in the past. A product of the cyclical nature of new drugs entering the market.

“Although there was indeed a dip in new drug introductions during the decade from 1997 to 2006, this was largely an artefact of a peak in 1997, which was itself preceded by an unusually low number of launches in 1985-87,” they write. “Additionally, the peak number of new drugs added to the BNF in 1997 was matched in 2010.”

The authors point out that their study does not distinguish between varying degrees of innovation, and launches are not the only indicator of pharmaceutical industry health. But theirs is the most up to date UK study of new launch trends, they say.

There are however, reasons to be concerned. As the authors point out, the costs of drug development have soared. and the time taken to bring a new drug to market has risen from 3 years in 1960 to 12 in 2000.

My own view is that the authors of the study published today may well be asking the wrong question; or at least using the wrong measure. It isn't the number of 'new' drugs that count; it is really how innovative they are and whether they really make a difference.

Alarm Bells

Alarm bells rang when it was announced recently that the world's leading pharmaceutical companies are downgrading the search for new treatments for Alzheimer's disease after the failure of a series of high-profile drugs trials.

Nor has there been the expected windfall following the sequencing of the human genome. Many leading scientists are disappointed that there have been few gene-centred drugs coming through from this project.

Tragically the genome project has sucked funding away from more traditional areas of research with little reward. A decade ago drug companies invested billions of dollars in genomic research and development. The shares of small genomics based companies went through the roof in a 'genomic bubble'.

In 2000 the then head of the drug company Novartis was reported to have observed “Data, data everywhere, and not a drug, I think.”

Genomics may be a misdirected quest for new drugs. There are few diseases or condition for which there is a specific gene. This is not surprising; genotype doesn't translate into phenotype.

Misdirected funding

Funding has been directed at 'translational' research in the absurd hope that this could somehow leap beyond the usual steps of scientific endeavour and discovery. It can't and it won't. But another problem of translational research is that it draws funding away from solid basic biomedical science from which new ideas will eventually come. 

Some of the really good innovative drugs have been founded on basic research. Genomics is more like a fishing expedition rather than good science. Major breakthroughs in treatment often come serendipitously rather than from targeting a problem and throwing money at it; but luck usually rides on good science.

This was certainly so for the developments of treatments for Asthma. It involved good basic science, good pharmacology and a bit of luck. It came in stages over time; first with the finding that adrenal extract could relieve symptoms, then the discovery of adrenaline and the categorisation of different adrenaline receptors which enabled drugs to be targeted at the right ones. It also involved understanding of how some drugs could act over time, and that more than one kind of drug was needed; one to relieve symptoms acting on the adrenaline receptors in the airway, and another, corticosteroid, to ease the inflammation.

The pharmaceutical industry needs to take stock and rethink its drug development strategy. Putting their eggs in the genomics basket will produce fewer answers then originally anticipated. Government and funding agencies need also to consider how to rejuvenate basic biomedical science and systems biology.

It is scandalous that drug companies should be giving up on diseases such as Altzheimer's. We should stop looking for magic bullets. Good science takes time and funding. Pharmaceutical companies looking for a quick buck have forgotten those basic ingredients.

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