Chasing Perfection

A hospital safety expert says it's now possible to completely eliminate certain adverse events. Pharma can't claim the same yet, but is it time for us to start imagining a time when we can "benchmark perfection"?

R&D Innovation: An Answer to Cancer

Cancer R&D IS booming right now. At a time of poor ratings on both Wall Street and Main Street, pharma can at least point proudly to its oncology pipeline as proof that it still takes big risks to make big advances against big killers—and win. According to a recent IMS report, the cancer pipeline contains 380 compounds, with nearly 100 in Phase III. The long-established standard of care—surgery, radiotherapy, and chemo—is fast giving way to a high-tech array of targeted therapies. These molecules and antibodies are designed to block specific disease pathways, and they are proving both far more effective and far more tolerable than the sledgehammer status quo. Since 1996, the overall survival rate for patients has jumped by 30 percent, from one-half to two-thirds.

Are We Safer Yet?

FDA has just premiered a new newsletter on drug safety. There's just one little problem....

What Do You Say?

In this issue, a longtime contributor to this magazine, former FDA official, and generally thoughtful, knowledgeable person concludes his excellent three-part series on drug safety with a look at how risk is communicated to patients and doctors. It's a fine, detailed, subtle piece of work, and I recommend it to you. (See "Failure to Communicate".)

The Price is Wrong

Of all pharma's marketing tactics, the hardest to swallow was "marketing the spread." This was a scheme developed in the 1990s for physician-administered drugs (PADs)—injectables, cancer drugs, etc., which are purchased from wholesalers by physicians and reimbursed by Medicare or third-party payers. Until recently, reimbursement was based on Average Wholesale Price (AWP). This sounds like it ought to mean the average of prices paid to wholesalers, but in practice, it was always closer to sticker price. Manufacturers discovered that they could give physicians a tidy bonus by creating a spread between AWP and what docs paid.

Post-regulatory

The Acomplia story isn't ending. It's just beginning. Get ready to see what happens when a much-desired drug is marketed by people accountable to no one.

From the Editor: Not His Problem

It's not FDA's job to make doctors and patients take more responsibility for using drugs wisely. But whose job is it? Really, whose?

The View From Inside

There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events

From the Editor: Second Thoughts