Drug Baron

July 8, 2014
by admin

Twenty six of the best candidate protein biomarkers have no ability to predict Alzheimer’s Disease

DrugBaron woke up this morning to the latest chapter in the “blood test for Alzheimer’s Disease” soap opera, with this article from the BBC trumpeting the latest study to be published as a “major step forward”.

The study behind the headlines was published (unusually for a “major breakthrough”) in the journal Alzheimer’s & Dementia, and described a study based on the measurement of 26 candidate protein biomarkers in blood samples from 1,148 individuals, 476 with Alzheimer’s Disease, 220 with mild cognitive impairment (MCI), and 452 controls of similar age but no dementia.

The authors of the study, and their industrial collaborators at Proteome Sciences plc, were not backward at promoting this work as a significant: Dr Ian Pike, Chief Operating Officer at Proteome Science declared “Having a protein test is really a major step forwards.  [It] will take several years and need many more patients before we can be certain these tests are suitable for routine clinical use, that process can start fairly quickly now.”

Even independent voices were quick to praise the new research: Eric Karran, Director of Research at Alzheimer’s Research UK, described the study as a “technical tour de force”.  Really?

This is, after all, not the first 2014 paper to make such a claim: in March a paper in Nature Medicine made almost identical claims, and BBC article reporting that study even used many of the same stock images!  Even the headline claims of the two studies were similar (90% accuracy for the Nature Medicine paper verus 87% accuracy for the new study).  And both used similar methodology: multivariate signatures, although the earlier study was focused on metabolic biomarkers and the new study on proteins.

So did the new study justify the hype any more than the previous attempts to solve this important problem? DrugBaron reviewed the primary publication with interest.

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June 26, 2014
by admin

“On the way to changing the world, there are no signposts” : the illusory power of precedents

Precedents play a central role in the drug development industry.  Clinical trials are based on earlier studies with ostensibly similar drug candidates.  Business models are judged against the current landscape.  Assets are valued by looking for comparables.  Indeed, big pharma consider the institutional accumulation of such experience to be a significant competitive advantage.

But if you stop and think about it, such an approach makes no sense if you seek true innovation.  The premise of all innovation is that it breaks the mould, changes the goalposts, disrupts the marketplace.  Aiming to change the world, and then judging your progress against historical norms isn’t just meaningless – some precedents can lead you down blind alleys or drive altogether the wrong decisions.

DrugBaron examines a number of recent examples of misapplied precedents to illustrate why, when searching for the breakthrough that changes everything, forwards is the only way to look.

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June 2, 2014
by admin

Cometh the saviour? Casting Valeant’s J. Michael Pearson in a new role

There has been much written about the proposed acquisition of Allergan by Canada’s Valeant – most of it doom-laden.  Much of the commentary paints a picture of a post-apocalyptic landscape, with marauding capitalists slashing and burning cherished R&D facilities.

And the villains of the piece are Valeant’s CEO J. Michael Pearson, playing Darth Vader to Pershing Square’s Bill Ackman as the Emperor Palpatine.

What did they do to unleash such a barrage of criticism and predictions of doom?  Was it anything more than point out the unsustainable inefficiency of drug discovery and drug development as practiced by sizable pharmaceutical and biotech companies?  If so, then DrugBaron is the next Anakin Skywalker following in their footsteps, guilty of the same indiscretion.

At the heart of the case against them is the charge of “short-termism” – that their strategy will yield a fast buck for their shareholders today, but will ultimately destroy the essential infrastructure for innovation, harming patients and – in the long run – healthcare investors.

Its an argument that’s been made before to defend entrenched but uneconomic practices in other industries: car manufacturing in Western countries resisted the arrival of robotic efficiency from the Orient for decades, citing the need to protect jobs and local manufacturing capability.  But these latter-day Canute’s cannot resist the rising tide for ever, and eventually a seismic shift in manufacturing took place anyway.

Pearson, then, is not the destroyer of a magnificent pharmaceutical industry, but its saviour.   Only by deconstructing uneconomic R&D infrastructure and strategies is there any hope for societies continued investment in healthcare innovation.

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