Pharmaceutical Executive-12-01-2006

It's important that the new class and Galvus successfully replace TZDs and sulfonylureas first, then outperform our competitor second. But in the end, we still want to be the leader.

The Medicare Modernization Act set the stage for rapid and easy conversion to government-controlled pricing and the adoption of government pricing by private payers.

Who should make decisions about drug safety-FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.

Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.

To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest.

Even when NICE has said that drugs should be available to anyone who needs them, patients still have to convince their Primary Care Trusts.

Peter Rost, former Pfizer executive turned whistleblower, isn't just at war with his old employer. He's crusading against all of pharma, an industry he likens to the mob.

Doctors like direct mail as long as the message is concise and to the point. The minute you ask the doctor to actually do something with the direct mail, that's when your effectiveness starts to go downhill.

This year's Pipeline Report profiles 32 compounds that are the early fruit of pharma's investment in targeted drug design. In diabetes, HIV, hepatitis C-and especially oncology-vibrant R&D is set to revolutionize treatment with new classes of drugs over the coming decade. We spotlight today's geeky names-the DPP-IVs and MK-0518s, the Tykerbs and Telaprevirs-that are most likely to be tomorrow's glam blockbusters. Even the year's downers-we're still waiting on Acomplia, Exubera is failing to live up to the hype-are reminders of how improvements in drug development, such as Phase 0, are helping industry in its drive to become more effective. Although riskier than squeezing me-too drugs out of proven products, targeted R&D is lighting pathways not only to cures of killer diseases but to a fresh paradigm of progress and profits, and to renewed confidence in the pharmaceutical industry. From where we stand, the future looks bright.