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[e-drug] Is that it, then, for blockbuster drugs?

E-DRUG: Is that it, then, for blockbuster drugs?
[Serious criticism for big farma, from the Lancet, Volume 364 Issue 9440, 25 
Sept 2004, page 1100.  Copied as fair use; WB]


Is that it, then, for blockbuster drugs?

2 weeks ago, an Advisory Committee to the US Food and Drug Administration (FDA) 
rejected an application for ximelagatran, AstraZeneca's new thrombin inhibitor. 
The Committee cited worries about liver toxicity, which has led to three 
deaths, together with doubts about the company's plans to monitor and manage 
liver complications. 

No one doubts that an alternative to the hard to use, and consequently 
underused, warfarin is needed. Ximelagatran was to be indicated to prevent 
venous thomboembolism, especially after total knee replacement, and to prevent 
strokes in patients with atrial fibrillation. 

Ximelagatran has stumbled at this regulatory hurdle, for the moment at least; 
the company is urgently negotiating with the FDA. Does this failure for another 
hoped-for blockbuster drug reflect a greater malaise in the pharmaceutical 
industry and auger badly for the future? Quite probably, yes. The age of the 
blockbuster drug seems over, or at least in its last days. 

The problem is that the pharmaceutical industry has not been as innovative as 
it claims to be, a failing reflected in the falling stock-market performance of 
many large companies. Most of the big pharmaceutical manufacturers spend more 
on marketing than on research and development. In last-ditch flings at seeking 
new markets, the drugs industry can only come up with new indications for old 
drugs and me-too compounds to barge into existing markets. 

What has gone so wrong? Are all the known drug receptors saturated with 
existing compounds, as it were, such that no new drugs are needed? Certainly 
not, since current treatments are not effective enough, and safety profiles 
could well be improved. Drug companies actively research for new ways to 
interact with known receptors and seek out new receptors. But the development 
road is long, stony, and expensive, as seen with ximelagatran. 

The traditional route to drug discovery, the old pharmacology of testing 
analogues of active drugs or the slightly newer pharmacology of mass screenings 
in chemical libraries, is not yet over. But neither has rational drug 
design--the new pharmacology of characterising the receptor and making a drug 
to fit--come up with a blockbuster, although it may do one day. Such rational 
research has led to licensed drugs, but they are mostly for rare diseases (eg, 
imatinib for gastrointestinal stromal tumours) or are barely effective, even in 
combination with traditional therapies (eg, trastuzumab for some advanced 
breast cancers). 

The challenge is set for drug companies to become truly innovative. A good 
start would be to forget the me-too market (after compounds three and four are 
licensed) and to go and find those receptors, old and new, and the genuinely 
new compounds to interact with them. * The Lancet

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