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发帖数: 1526 | 1 http://www.nature.com/news/2011/090211/full/470141a.html
Pharmaceutical industry must take its medicine
To fix the drug pipeline, governments must take on drug-makers instead of
capitulating to their every demand, says Colin Macilwain.
Pfizer's announcement last week that it is to pull the plug on its drug-
development laboratory in Sandwich, Kent, and fire most of its 2,400 staff (
see page 154), must be a wake-up call for scientists and policy-makers alike
. The pharmaceutical industry is taking them for a ride. Drug executives
know that, however they behave, public money will continue to flow into the
industry from spending on basic research and the purchase of final products.
For almost a decade now, drug-makers such as Pfizer have claimed that they
can maintain huge research and development expenditures despite the
increasing rarity of new 'blockbuster' drugs. This serves two purposes: it
has persuaded investors that there is, really, something lucrative in the
pipeline; and it has beguiled politicians into throwing public money at the
early stages of drug development.
The closure of the labs in Sandwich is a sure sign that this process isn't
delivering, in Britain or elsewhere. That is despite massive government
investment — notably from the US National Institutes of Health, whose US$32
-billion budget is chiefly devoted to finding ideas for the industry.
Big pharma's fashionable younger brother, biotechnology, is not doing much
better. It is experiencing the deepest and most prolonged slump in its 35-
year history. When the most successful US biotechnology company, Amgen of
Thousand Oaks, California, is taken out of the picture, the industry has
never made a profit, as Gary Pisano, who studies technology strategy at
Harvard Business School in Boston, Massachusetts, showed in his book Science
Business (Harvard Business School Press, 2006). The 2010 report How to
Compete and Grow: A Sector Guide To Policy, released by the McKinsey Global
Institute in New York, found that biotechnology is unlikely to generate
significant job growth. And The Bioeconomy to 2030, published by the
Organisation for Economic Co-Operation and Development in Paris in 2009,
noted that 75% of the economic impact of the life sciences is likely to be
outside the health sector.
Yet the main thrust of scientific and regulatory policy in both Europe and
the United States for ten years or more has been to give the leaders of the
'life-sciences industry' whatever they want, in the expectation that they
will generate export earnings and highly paid jobs.
The most visible current features of British and US biomedical research
policy are a pair of publicly funded megaprojects aiming to remove blockages
in the drug pipeline. The planned UK Centre for Medical Research and
Innovation in London and the proposed National Center for Advancing
Translational Sciences at the US National Institutes of Health in Bethesda,
Maryland, have their merits; those of the latter project were spelled out by
Garret FitzGerald in this space, last December.
But the political architects of these projects are applying their attention
to the wrong part of the plumbing. It isn't just the stretch of pipeline
that translates laboratory findings into drug candidates that is failing; it
is drug development itself. If we want better value from investment in
health research — not to mention the immense expenditure on drug treatments
— then we need to upend the drug industry's operating model.
Policy-makers should look again at control of intellectual property and
regulation. The grip of patenting on the life sciences has tightened,
particularly since the World Trade Organization's international Trade-
Related Aspects of Intellectual Property Rights agreement came into full
force a decade ago. This tightening is what the industry wanted — it has
bolstered profits and reduced drug piracy — but there is little evidence
that it has increased the flow of innovative therapies.
More free exchange of information would be awkward, and innovation models
such as that of the computer industry, where patented ideas are constantly
swapped and resold, cannot be directly applied to drug development. However,
many scientists — including, one suspects, the Pfizer staff too scared to
talk to the BBC in Sandwich last week — are fed up with the secrecy and
inefficiencies of the existing system, best exemplified by the fact that
many clinical trials data never see the light of day. The regulatory system,
meanwhile, is often blamed by the pharmaceutical industry for its problems
— but actually serves the industry well, by setting up high barriers to
entry.
Alternative approaches have been suggested. The Manchester Manifesto,
published in November 2009 by a group led by John Sulston, a biologist, and
Joseph Stiglitz, an economist, both at the University of Manchester, UK,
called for a new approach to the sharing of knowledge and data. Joyce Tait,
a policy analyst at the University of Edinburgh, UK, has argued that a more
flexible regulatory system (enabling, for example, drug trials on patient
subgroups selected for their genetic susceptibility to certain treatments)
could open the field to more players.
Scientists haven't embraced such possibilities aggressively enough, and
politicians have barely engaged with them at all. They prefer to look to
industry for advice on research and regulatory policy, and then beg it for
favours. UK Prime Minister David Cameron even said in a speech last month
that he had called Ian Read, Pfizer's chief executive, to inform him of yet
another planned tax break, exempting revenue earned from patents held in
Britain from corporation tax. His reward? Another 2,000 people unemployed.
Colin Macilwain is a contributing correspondent with Nature. e-mail:
c**********[email protected] | L*******a
发帖数: 824 | 2 very good article
the problem with innovation is the cost and risk is too high, yet the profit
is not high enough.
Generic drugs are even more profitable than developing new drugs and it is
going to ruin the pharma industry by turning it into a manufacturing and
sales business | m****n
发帖数: 1066 | | c*******u
发帖数: 88 | 4 The high risk development projects should be undertaken by the academia and
government institutions, not the industry. The industry's strength really is
with their development pipeline, CMC, clinical trials, etc. that can
capitalize on really promising candidates.
What the pharma industry did wrong in the past is that they have spent too
much money raising a huge poor of expensive scientists who simply do the
same work as what they'll be doing in an academic lab - cell biology,
biochemistry, screening, etc. and more often the results of these expts are
not published because most candidates fail.
So the government should be more aggresively fund early-stage discovery
projects, and even the pharma could invest in more university collaboration
ventures. |
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