Dear all,
The following article from today's Financial Times is absolutely worth
the read.
It find the industry's perspective unbelievable! Read on for some
entertainment....
Warning over drug trial’s effects on testing
By Andrew Jack in London
Published: May 13 2008 22:07 | Last updated: May 13 2008 22:07
A pioneering clinical trial launched this year by a US-backed research
institute may fundamentally reshape relations between payers and the
pharmaceutical industry, IMS Health, the healthcare consultancy, warned
on Tuesday.
The National Eye Institute-sponsored $16m ”head to head” trial will
compare the effectiveness of two drugs produced by Genentech, the
biotech company controlled by Roche of Switzerland, and could lead to a
much cheaper way to treat Age-Related Macular Degeneration (AMD), which
causes blindness.
IMS says the study, called CATT, opens ”a Pandora’s box” for the drug
industry by taking testing out of the hands of the companies, changing
the rules of development and potentially undermining a blockbuster long
before it comes off patent.
It describes CATT as one of the top seven ”harbingers of change” for
2008 highlighted in its yearly analysis of significant events likely to
affect the evolution of the pharmaceutical sector.
The trial, unveiled last month and set to conclude in 2010 without any
involvement from Genentech, may result in prescribers widely switching
from Lucentis, developed for AMD, to Avastin, developed for cancer but
which can be split into small doses for injection into the eye at a
fraction of the cost.
Lucentis was specifically tested for safety and efficacy in treating AMD
and approved by the US Food and Drug Administration in 2006, but it is
closely related to Avastin, which was approved for cancer in 2004 and
since then widely prescribed by discretion by doctors ”off label” beyond
the officially authorised uses.
With a single dose of Lucentis for AMD costing $2,000, many doctors have
already switched to the use of the much larger concentration available
in a single bottle of Avastin, which can then be split to cost only
$40-75 for each injection, reducing total average treatment costs from
$24,000 to $900.
IMS argues that if CATT, the Institute’s study, shows Avastin to be as
safe and effective for AMD as Lucentis, it may pave the way for an
increasing number of payers to take comparative drug studies out of the
hands of the pharmaceutical companies, especially as databases of
patients make it much easier to conduct such tests.
But it warns that the move may create a disincentive for companies to
study such areas, and creates untested areas of who would approve
Avastin for AMD following a late-stage Phase 3 clinical trial which was
conducted without any of the usual early-stage testing regulators
usually require.
Copyright The Financial Times Limited 2008
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