One of the most interesting and a pharma-world-shaking event has been the ‘withdrawal’ of torcetrapib. SO WHAT IS TORCETRAPIB?
Torcetrapib (CP-529414, Pfizer) was a drug being developed to treat hypercholesterolemia (elevated cholesterol levels) and prevent cardiovascular disease. It acts by inhibiting cholesterylester transfer protein (CETP), resulting in higher HDL cholesterol levels (the "good" cholesterol-containing particle) and reducing LDL cholesterol levels (the "bad" cholesterol). Development of the drug began around 1990; it was first administered in humans in 1999, and manufacturing at production scale began in Ireland in 2005.
Pfizer had previously announced that torcetrapib would be sold in combination with Pfizer's statin, atorvastatin (Lipitor); however, following media and physician criticism, Pfizer had subsequently planned for torcetraipib to be sold independently of Lipitor. A 2004 trial showed that torcetrapib could increase HDL and lower LDL with and without an added statin.
On December 2, 2006 Pfizer cut off torcetrapib's trial because of "an imbalance of mortality and cardiovascular events" associated with its use. This was a sudden and unexpected event and as recently as November 30 Jeff Kindler, Pfizer’s chief executive, was quoted as saying "This will be one of the most important compounds of our generation." In the terminated trial, a 60% increase in deaths was observed among patients taking torcetrapib and Lipitor versus taking Lipitor alone; there was not suggestion that the results called into question the safety of Lipitor. Pfizer recommends that all patients stop taking the drug immediately
This reminds one of Vioxx withdrawal.
Actually the two events ie torcetrapib withdrawal and Vioxx (rofecoxib) withdrawal ought to set off deep soul searching in the healthcare and pharma world. In fact, the blog world too is shaken up with this latest million dollar loss event. Please see the blog: http://www.pharmamkting.blogspot.com for interesting posts.
One important question at this juncture is ARE OUR PHARMA COMPANIES HAVING THE RIGHT ORGANISATIONAL DESIGN TO SUPPORT INNOVATION?
Traditionally pharma companies have a top heavy hierarchical command and control structure, with very little lateral functioning. In fact, the world over, knowledge oriented companies that thrive on creativity and innovation are ‘flatter’. As such flat organizations encourage horizontal communication and lots of internal debate. GE & Infosys prefers the flat organizational concept. Furthermore, to respond successfully to the challenges of a competitive marketplace, Price Waterhouse (in 1992) has also suggested The Benchmarking Organisation (with Rank Xerox as examplar), The Innovative Organisation (3M), Business Process Redesign (Ford), The Networking Organisation (BP), The Learning Organisation (Rover) and The Hollow Organisation (Benetton) as successful models. These organisational structures will foster better innovation management and better R & D results. This means better use of scarce resources and will certainly insulate the company and society from disasters like the torcetrapib and rofecoxib marketing waterloos.
Another important role is of a COLLABORATIVE APPROACH to commercializing the R & D molecules. For eg. Glenmark in India has a specific collaborative R & D approach to commercialize its innovations. In return the company receives mile stone payments from its foreign partners. This way there is better vetting of one’s R & D efforts.
The basic idea is to reduce R & D risks & reduce loss of monies through commercialization failures.