John LaMattina a contributor at Forbes caught my attention with the following headline “Should The Marketing Division Set Strategy For Pharmaceutical R&D?” He presents a fair and balanced look at this idea starting with a quote from George W. Merck
“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.” (taken from “Built to Last, James C. Collins and Jerry I. Porras, 1994)
And he presents the reality that back in the olden days it was simpler to go from idea to market and cheaper too. Okay I’ll buy into that. And he ends with the need for a strong bond between scientists and the commercial dudes. Mom and apple pie. Somewhere in the middle he makes the case for the long-term testing in patients for safety, efficacy, and differentiation from current standard of care.
He lost me here. Differentiation means, at least to me, you compare the compound to a competitor. Nearly all drug trials are comparing to placebo and rarely compare to the leading standard of care drug in the category and for good reason. If I’d had spend $100s of millions to get here why risk it in a head to head comparative trial. As in the link below.
But that is changing and we will be seeing more and more of this: “Glaxo’s diabetes drug fails to beat Takeda’s Actos in head-to-head study” If you want to claim superiority head-to-head will be required.