Friday, June 4, 2010

The future of drug development: Is this it?

The irony cannot be lost here.

Can Steve Nissen, the cardiologist industry loves to demonize, show Pharma how to shorten the length of a clinical trial, save money on it as well and --- on top of all that – prove to the world that KOLs continue to have an indispensable place in the future of medicine?

Nissen, the department chair of cardiovascular medicine at the Cleveland Clinic in Ohio, and an FDA adviser, is lending his considerable clout to an ambitious trial that is teaming up Pfizer’s Lipitor with a version of a thyroid hormone that, when given together, reduces cholesterol levels as reported on

This hormone, created by the Swedish pharmaceutical company Karo Bio AB, is called eprotirome, and according to Bloomberg, works in such a way that the FDA will require that it undergoes extensive testing. Who will make the key management decisions; how will this compound be developed differently than products of the past? Will Dr. Nissen talk publicly about his relationship with this company? The media apparently hasn't asked this question yet. But even more important, has drug development gotten so expensive that it might not be able to be completed without significant cost?

These studies will still take considerable time and money, both of which Karo doesn’t have – Karo has no products on the market, Bloomberg says. What Nissen and Karo are talking about is testing the combination on massive numbers of people, with the trial lasting about three years. Imagine the cost of such a trial. "If regulators clear Karo’s limited scope for research, it will still cost $300 million or more," said Erik Hultgard, an analyst at Handelsbanken Capital Markets in Stockholm. Is this the future of drug development for small- and medium-sized companies? We certainly believe that the development model needs to change. Should a shorter, more evidence-based approach to drug development be used?

Let us all hope that Nissen and Karo are successful, as everybody wins here.

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